FDA Recalls of Dietary Supplements
684 FDA enforcement records describe a dietary supplement, from 265 firms. 97 DSLD labels share a UPC with a recalled product, and 60 of those are still on the market.
The FDA publishes every recall it tracks as an enforcement record, with the recalling firm, the product, the reason, and a hazard class. We took the records whose product description says "dietary supplement" or "nutritional supplement" (a snapshot of the openFDA food and drug enforcement data, fetched 2026-10-11) and compared them with the labels in the NIH Dietary Supplement Label Database (DSLD). Nothing here rates a brand or tells you what to buy; it shows what the FDA recorded and which DSLD labels the records can be tied to.
Why supplements are recalled
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Reasons are grouped by keyword from the FDA's own wording, which is quoted in full in the tables below. A record can fit more than one group; each is counted in the first that matches, in the order undeclared drug, undeclared allergen, microbial, other undeclared ingredient, unapproved claims, contaminants, cGMP, potency or quality.
By year reported
| 2012 | 13 | |
| 2013 | 113 | |
| 2014 | 87 | |
| 2015 | 45 | |
| 2016 | 71 | |
| 2017 | 131 | |
| 2018 | 29 | |
| 2019 | 18 | |
| 2020 | 26 | |
| 2021 | 39 | |
| 2022 | 12 | |
| 2023 | 22 | |
| 2024 | 16 | |
| 2025 | 43 | |
| 2026 | 19 |
By hazard class
| Class II | 377 |
| Class I | 189 |
| Class III | 118 |
Class I is the most serious hazard, class III the least. A class says how risky the problem is, not how many bottles were affected.
Recalled products that match a DSLD label
A UPC identifies one product, so when a recall record carries a UPC that also appears on a DSLD label, they are the same product line. 97 DSLD labels match: 60 are listed as on the market and 37 as off the market. A recall often covers only some lots, so a match does not mean every unit of the product was affected; the lot or code information from the FDA record is shown beside each match. Most records carry no UPC at all, so this list is a minimum.
Listed as on the market
| Product | Recall | Reason (FDA wording) | Lot / code information |
|---|---|---|---|
| Prenate Chewable (Avion Pharmaceuticals) | H-0233-2026 2025-12-10 · Class III | Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving. | Product Code 75854-306-30 Lot 2402036 Exp 2026-04 Lot 2402036A Exp 2026-04 & Lot 2412020 Exp 2027-02 |
| Prenate Chewable Chocolate (Avion Pharmaceuticals) | H-0233-2026 2025-12-10 · Class III | Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving. | Product Code 75854-306-30 Lot 2402036 Exp 2026-04 Lot 2402036A Exp 2026-04 & Lot 2412020 Exp 2027-02 |
| Vitamin B-12 Gummies Raspberry Flavor (Rise-N-Shine) | H-0037-2026 2025-10-08 · Class II | Undeclared Peanuts. The firm was notified by their supplier, that the product may contain undeclared peanuts. | 1. LOT# 57221A BEST BY: 07/2026 and Lot# 56199 Best By: 07/2026 2. Lot# 57664 Best By: 07/2026 |
| Target-Mins Calcium Magnesium With Vitamin D3 Complex Blueberry Flavor (Country Life) | F-2196-2014 2014-07-30 · Class II | The affected lots do not meet quality standards due to insoluble particulates. | Code 2523: Lot 1112H6-G16 (16 fl. oz), Code 2522: Lot 1112H6-G32 (32 fl. oz.) |
| Target-Mins Calcium Magnesium With Vitamin D3 Complex Blueberry Flavor (Country Life) | F-2196-2014 2014-07-30 · Class II | The affected lots do not meet quality standards due to insoluble particulates. | Code 2523: Lot 1112H6-G16 (16 fl. oz), Code 2522: Lot 1112H6-G32 (32 fl. oz.) |
| Vitamin D-3 (Source Naturals) | F-2178-2017 2017-05-10 · Class II | Testing of Vitamin D-3 as a result of a consumer complaint found specific lots to have lower concentrations than product specifications of ingredient labeling. | Lot number/expiry date SN22274: 1 oz bottle: FG-77168, 03/19; FG-72299, 09/18; FG-73645, 09/18; FG-63547, 01/18; FG-55486, 08/17; FG-55923, 08/17; FG-59576, 08/ |
| Vitamin D-3 (Source Naturals) | F-2178-2017 2017-05-10 · Class II | Testing of Vitamin D-3 as a result of a consumer complaint found specific lots to have lower concentrations than product specifications of ingredient labeling. | Lot number/expiry date SN22274: 1 oz bottle: FG-77168, 03/19; FG-72299, 09/18; FG-73645, 09/18; FG-63547, 01/18; FG-55486, 08/17; FG-55923, 08/17; FG-59576, 08/ |
| Carnivor Fruit Punch (MuscleMeds) | F-2150-2017 2017-05-03 · Class II | A raw material initially failed testing Staphylococcus aureus. A retest was conducted with passing results but an out of specification investigation was not properly conducted leaving concern that the finished product could contain the bacterium. | (a) lot IM445587, Exp 07/2019 (b) lot IM449808, Exp 07/2019 |
| Mr Hyde Intense Energy Pre Workout Green Apple (PS ProSupps) | F-1783-2015 2015-04-08 · Class II | The product contains more yohimbine hcl than declared on the label | UPC: 682055405483, Lot # 0116L1 and 0117L1 |
| Challenge (Loomis Enzymes) | F-1551-2013 2013-07-03 · Class II | Enzymes Formulations Inc. is recalling Enzyme Solutions Formula 29 8 oz., lot 1225822 because of a labeling error at the manufacturing. This resulted in 10 jars incorrectly containing a Multiple Enzyme Powder. | Lot 1225822 |
| Active Seniors Unflavored (All One) | F-1339-2013 2013-05-01 · Class II | Product label misprinted to include claim of "No Dairy", even though milk is present in an ingredient (whey protein isolate). "Certified Vegan" is also claimed on the product label. The Supplement Facts panel and side panel discusses the presence of milk in the product. | UPC: 0 52534 40008 5, Lot No. 170502, Use By: 01/15. |
| Combat Powder Banana Cream (MusclePharm) | F-1298-2013 2013-04-17 · Class II | One lot of each product may have extraneous materials due to a problem on the packing line. | Lot # 123732 027, Expiration date 02/2015 |
| Combat Powder Cookies 'N' Cream (MusclePharm) | F-1297-2013 2013-04-17 · Class II | One lot of each product may have extraneous materials due to a problem on the packing line. | Lot # 123932 026, Expiration date 02/2015 |
| Blood Sugar (Host Defense Mushrooms MycoBotanicals) | F-1231-2019 2019-04-10 · Class II | Host Defense MycoBotanicals Blood Sugar, 60 ct. bottles, is recalled due to undeclared wheat. | 100217 EXP: 10/20 101718 EXP: 10/21 080918 EXP: 08/21 (Canada) Lot code is the date of encapsulation, expiration is set as month/year 3 years from month of manu |
| Extreme NOS Pumped Double Berry (MET-Rx) | F-1224-2013 2013-03-27 · Class III | The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage. | Lot # 470645, exp. 11/30/2013 |
| Extreme NOS Pumped Watermelon (MET-Rx) | F-1223-2013 2013-03-27 · Class III | The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage. | Lot 460259, exp. 10/31/2013; Lot 464764, exp. 12/31/2013 |
| 5-MTHF 1 mg (Kirkman) | F-1222-2024 2024-05-15 · Class III | Labeling error. The 5-MTHF 1mg label incorrectly declares 5000mcg Folic Acid instead 1000mcg Folic Acid per serving in the Supplement Facts, but correctly declares Folate 1667mcg DFE. The front label correctly declares product as 5-MTHF Methyltetrahydrofolate 1mg (or 1000mcg). | Lot#: 477-0016, Exp: 08/2025 |
| Organic Iron Drops (Wellements) | F-1148-2020 2020-08-19 · Class I | Product contains undeclared milk | Lot 10592 BB 10/2020 |
| Organic Iron Drops (Wellements) | F-1147-2020 2020-08-19 · Class I | Product contains undeclared milk | Lot 18491 BB 1/2021, Lot 10592 BB 10/2020 |
| Flo (OneBode) | F-1112-2014 2013-12-25 · Class II | The finished dietary supplement product was manufactured with ingredients found to be contaminated with chloramphenicol, an antibiotic, above levels of 0.3 ppb. | (a) Lot Number 1262057; (b) Lot Number 1262058; (c) Lot Numbers 26813, 26813A, 26813B |
| Extreme Themo Rage Watermelon (MET-Rx) | F-0980-2013 2013-02-13 · Class III | Acetobacter lovaniensis was detected in a sample of the product tested by a private laboratory. This is an issue of commercial spoilage. | Lot # 430855, Expiration Date 12/21/12; Lot # 430856, Expiration Date 12/29/12 |
| Hydrolyzed Collagen Peptides (Solumeve) | F-0846-2021 2021-08-18 · Class I | Informed by contract manufacturer that the MCT ingredient used in their product was under recall due to undeclared milk. | Finished Product Lot No.: 03011; Expiration Date: 11/2/2023 Item No.: SLM-01828 |
| Bliss (Market America) | F-0681-2020 2020-02-19 · Class II | Potentially undeclared Yohimbe 83 and complaints of adverse reactions: upset stomach, jittery, sweaty, lightheaded or dizzy. | Lot #: 51130, Expiration Date: 07/2019 Manufacturer's Code PK-MA13173 Manufacturer's Item #Z02320 |
| Isomorph 28 Honey Granola (APS) | F-0509-2021 2021-05-26 · Class I | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. | 2lb - All EXP DATES up to and including 02/2023 5lb - All EXP DATES up to and including 10/2022 |
| Isomorph 28 Honey Granola (APS) | F-0509-2021 2021-05-26 · Class I | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. | 2lb - All EXP DATES up to and including 02/2023 5lb - All EXP DATES up to and including 10/2022 |
| Isomorph 28 Delicious Vanilla Milkshake (APS) | F-0508-2021 2021-05-26 · Class I | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. | 2lb - All EXP DATES up to and including 09/2023 5lb - All EXP DATES up to and including 12/2021 |
| Isomorph 28 Vanilla Ice Cream Flavor (APS) | F-0507-2021 2021-05-26 · Class I | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. | 5lb - All EXP DATES up to and including 11/2022 |
| Isomorph 28 Delicious Strawberry Milkshake (APS) | F-0506-2021 2021-05-26 · Class I | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. | 2lb - All EXP DATES up to and including 11/2022 5lb - All EXP DATES up to and including 05/2021 |
| Isomorph 28 Smores Flavor (APS) | F-0505-2021 2021-05-26 · Class I | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. | 2lb - All EXP DATES up to and including 06/2023 |
| Isomorph 28 Orange Creamsicle (APS) | F-0504-2021 2021-05-26 · Class I | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. | 2lb - All EXP DATES up to and including 12/2022 5lb - All EXP DATES up to and including 12/2022 |
| Isomorph 28 Delicious Neapolitan Ice Cream (APS) | F-0503-2021 2021-05-26 · Class I | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. | 2lb - All EXP DATES up to and including 05/2021 5lb - All EXP DATES up to and including 05/2021 |
| Isomorph 28 Neapolitan Ice Cream (APS) | F-0503-2021 2021-05-26 · Class I | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. | 2lb - All EXP DATES up to and including 05/2021 5lb - All EXP DATES up to and including 05/2021 |
| Isomorph 28 Cookies & Cream (APS) | F-0502-2021 2021-05-26 · Class I | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. | 2lb - All EXP DATES up to and including 10/2023 5lb - All EXP DATES up to and including 09/2021 |
| Isomorph 28 Cookies & Cream (APS) | F-0502-2021 2021-05-26 · Class I | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. | 2lb - All EXP DATES up to and including 10/2023 5lb - All EXP DATES up to and including 09/2021 |
| Isomorph 28 Cinnamon Graham Cracker Flavor (APS) | F-0501-2021 2021-05-26 · Class I | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. | 2lb - All EXP DATES up to and including 06/2022 5lb - All EXP DATES up to and including 09/2021 |
| Isomorph 28 Delicious Chocolate Milkshake (APS) | F-0500-2021 2021-05-26 · Class I | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. | 2lb - All EXP DATES up to and including 04/2023 5lb - All EXP DATES up to and including 04/2023 |
| Isomorph 28 Delicious Chocolate Milkshake (APS) | F-0500-2021 2021-05-26 · Class I | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. | 2lb - All EXP DATES up to and including 04/2023 5lb - All EXP DATES up to and including 04/2023 |
| Isomorph 28 Delicious Chocolate Fudge Pop (APS) | F-0499-2021 2021-05-26 · Class I | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. | 2lb - All EXP DATES up to and including 05/2023 |
| Vita Biotic (Eclectic Herb) | F-0401-2025 2025-01-22 · Class III | Product's ingredients names such as Oregon Grape, Cayenne Root, and Ginger Fruit and their quantities were not listed correctly in the Supplement Facts panel. | Lot 25183; Exp date 10/2024 Lot 25543; Exp Date 03/2025 |
| A.I. Enzymes (Pure Encapsulations) | F-0397-2018 2017-12-06 · Class III | Product contains undeclared sulfites. | All lots within expiry. AI Enzymes 120: 50048025 50058242 50063516 50067188 50076912 50080121 50092381 50092382 50104459 50108093 50114435 50118464 50125714 AI |
| Systemic Enzyme Complex (Pure Encapsulations) | F-0396-2018 2017-12-06 · Class III | Product contains undeclared sulfites. | All lots within expiry. Lot/Serial Number: 50074561 50085867 50102085 50107811 50113681 50117860 50121029 50122279 50123772 50129551 |
| Fiber Plus Powder Apple Cinnamon (Ortho Molecular Products) | F-0340-2023 2023-02-15 · Class II | Raw material tested positive for Cronobacter sakazakii. | Lot 87121 Product Number 608445, 608445C, 608445CAN, and 608445U UPC 615033006082, 615033016081, 615033046088, and 615033606084 Expiration Date 06/30/23 Lot 870 |
| Tri-Vitamin Drops (Rugby) | F-0263-2017 2016-11-02 · Class II | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. | UPC No. 005368501800; Lot No. 20731506, Exp. Date 08/2017; Lot No. 20731603, Exp. Date 02/2018; Lot No. 20731604, Exp. Date 06/2018. |
| Tri-Vitamin Liquid (Rugby) | F-0263-2017 2016-11-02 · Class II | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. | UPC No. 005368501800; Lot No. 20731506, Exp. Date 08/2017; Lot No. 20731603, Exp. Date 02/2018; Lot No. 20731604, Exp. Date 06/2018. |
| Polyvitamin Drops (Rugby) | F-0262-2017 2016-11-02 · Class II | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. | UPC No. 005368450801; Lot No. 20701511, Exp. Date 09/2018; Lot No. 20701514, Exp. Date 12/2017; Lot No. 20701605, Exp. Date 05/2018; Lot No. 20701606, Exp. Date |
| Polyvitamin Liquid (Rugby) | F-0262-2017 2016-11-02 · Class II | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. | UPC No. 005368450801; Lot No. 20701511, Exp. Date 09/2018; Lot No. 20701514, Exp. Date 12/2017; Lot No. 20701605, Exp. Date 05/2018; Lot No. 20701606, Exp. Date |
| Fer-Iron Drops (Rugby) | F-0261-2017 2016-11-02 · Class II | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. | UPC No. 005360710801; Lot No. 21021510, Exp. Date 07/2017; Lot No. 21021601, Exp. Date 01/2018; Lot No. 21021602, Exp. Date 02/2018; Lot No. 21021604, Exp. Date |
| Fer-iron Liquid Delicious Natural Fruit Flavor (Rugby) | F-0261-2017 2016-11-02 · Class II | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. | UPC No. 005360710801; Lot No. 21021510, Exp. Date 07/2017; Lot No. 21021601, Exp. Date 01/2018; Lot No. 21021602, Exp. Date 02/2018; Lot No. 21021604, Exp. Date |
| Fer-Iron Drops (Rugby) | F-0260-2017 2016-11-02 · Class II | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. | UPC No. 005360710804; Lot No. 20901507, Exp. Date 07/2017; Lot No. 20901507, Exp. Date 11/2017; Lot No. 20901603, Exp. Date 05/2018 |
| Fer-iron Liquid Delicious Natural Fruit Flavor (Rugby) | F-0260-2017 2016-11-02 · Class II | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. | UPC No. 005360710804; Lot No. 20901507, Exp. Date 07/2017; Lot No. 20901507, Exp. Date 11/2017; Lot No. 20901603, Exp. Date 05/2018 |
| Ferrous Sulfate Elixir (Rugby) | F-0259-2017 2016-11-02 · Class II | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. | UPC No. 005360650858; Lot No. 22461511 & 22461512, Exp. Date 10/2017; Lot No. 22461513 & 22461514, Exp. Date 11/2017; Lot No. 22461515 & 22461516, Exp. Date 12/ |
| Cerovite Liquid (Rugby) | F-0258-2017 2016-11-02 · Class II | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. | UPC No. 005362790590; Lot No. 20471516, 20471517, 20471518, 20471519, & 20471520, Exp. Date 11/2017; Lot No. 20471521, Exp. Date 12/2017; Lot No. 20471601, Exp. |
| Calcionate Syrup (Rugby) | F-0256-2017 2016-11-02 · Class II | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. | UPC No. 005362770851, Exp. Date 06/2018. |
| Organic Infant Liquid Probiotic 100 Million CFU Unflavored (Mary Ruth's) | F-0214-2022 2021-12-01 · Class I | Internal testing found the presence of Pseudomonas aeruginosa in the product. | lots: 100420218, expiry 4/2023 and 100520218, expiry 5/2023 |
| Brain Charge (Source Naturals) | F-0061-2020 2019-10-30 · Class III | Labeling error; incorrect supplement facts panel and label claims for two ingredients were lower than the product formulation. | Lot Number: FG-99741, FG-100206, FG-99742, FG-100207 |
| Rauwolscine (Gorilla Mind) | F-0053-2025 2024-10-23 · Class I | Product was recalled due to the potential for contamination with Salmonella | Lot Number: 24041003 EXP: 04/2026 |
| Optimal Multivitamin Chewable (Seeking Health) | F-0048-2023 2022-10-26 · Class II | The product label claim for copper is 0.5mg, but third-party lab results revealed product contains higher levels of copper. | "LOT # 022221182, MFG 09/2021" and "LOT # 031022127, MFG 10/2021" Case Labels read in part: " LOT #: 022221182" and "LOT #: 031022127" |
| Bio35 (Pro-Biotiks) | F-0009-2018 2017-10-11 · Class II | Bio-35 has undeclared soy lecithin. | Lot# 2037055 Exp 06/12/2020 |
| Fem-Vite (Vinco's) | F-0008-2014 2013-10-30 · Class II | The soy ingredient used to manufacture certain lots of Vinco's Fem-Vite was potentially contaminated with Salmonella. | Fem-Vite UPC 739930205086, lot numbers 11080560, 11080562, 12100217, 12100218 with expiration dates 10/13 to 2/15. |
| Virt-Nate (Virtus Pharmaceuticals) | D-0775-2016 2016-03-23 · Class III | Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate). | Lot code M143810A, exp 7/2017, NDC 69543-264-10, UPC 369543264105, and Lot code M143810, exp 7/2017, NDC 76439-264-10, UPC 376439264109 |
Listed as off the market (37)
| Product | Recall | Reason (FDA wording) |
|---|---|---|
| Taurine (Prime Nutrition Precision Series) | H-0598-2025 | Unapproved Drug Claims and Misbranded. |
| Phytoform Fruits & Greens Formula Kiwi-Strawberry (Prime Nutrition Performance Series) | H-0597-2025 | Unapproved Drug Claims and Misbranded. |
| W700 (Ubervita) | F-2323-2015 | It has come to the attention of Ubervita LLC that a packaging error has occurred with a product exclusively made for Walmart Stores. This issue applies to less than 30 units of its W700 Lose Weight product. While the vitamin bottles are labeled accurately, less than 30-bottles of UBERTEST TESTOSTERONE EXTREME BOOST FOR |
| Liquid Target-Mins Calcium-Magnesium Natural Wild Blueberry Flavor (Country Life) | F-2196-2014 | The affected lots do not meet quality standards due to insoluble particulates. |
| Liquid Target-Mins Calcium-Magnesium Natural Wild Blueberry Flavor (Country Life) | F-2196-2014 | The affected lots do not meet quality standards due to insoluble particulates. |
| Liquid Target-Mins Calcium-Magnesium Natural Wild Blueberry Flavor (Country Life) | F-2196-2014 | The affected lots do not meet quality standards due to insoluble particulates. |
| Target-Mins Calcium Magnesium Wild Blueberry Flavor (Country Life) | F-2196-2014 | The affected lots do not meet quality standards due to insoluble particulates. |
| Target-Mins Calcium Magnesium With Vitamin D3 Complex Wild Blueberry Flavor (Country Life) | F-2196-2014 | The affected lots do not meet quality standards due to insoluble particulates. |
| Vitamin D-3 (Source Naturals) | F-2178-2017 | Testing of Vitamin D-3 as a result of a consumer complaint found specific lots to have lower concentrations than product specifications of ingredient labeling. |
| Vitamin D-3 (Source Naturals) | F-2178-2017 | Testing of Vitamin D-3 as a result of a consumer complaint found specific lots to have lower concentrations than product specifications of ingredient labeling. |
| Alphamine Raspberry Lemonade (Physique Enhancing Science) | F-2054-2014 | Products contain "Aegeline" an unapproved New Dietary Ingredient. |
| Alphamine Fruit Punch (Physique Enhancing Science) | F-2054-2014 | Products contain "Aegeline" an unapproved New Dietary Ingredient. |
| Live (Reaction Nutrition) | F-1879-2013 | The product contained an undeclared allergen, Colostrum, which is considered a dairy product and therefore requires an allergen statement on the label. |
| Prescript-Assist (LL Magnetic Clay) | F-1675-2018 | The recalled dietary supplement has the potential to contain undeclared allergens, including almonds, shellfish, milk, eggs, and peanuts. |
| Prescript-Assist (LL Magnetic Clay) | F-1675-2018 | The recalled dietary supplement has the potential to contain undeclared allergens, including almonds, shellfish, milk, eggs, and peanuts. |
| Prescript-Assist (LL Magnetic Clay) | F-1675-2018 | The recalled dietary supplement has the potential to contain undeclared allergens, including almonds, shellfish, milk, eggs, and peanuts. |
| Challenge (Loomis Enzymes) | F-1551-2013 | Enzymes Formulations Inc. is recalling Enzyme Solutions Formula 29 8 oz., lot 1225822 because of a labeling error at the manufacturing. This resulted in 10 jars incorrectly containing a Multiple Enzyme Powder. |
| Challenge (Loomis Enzymes) | F-1551-2013 | Enzymes Formulations Inc. is recalling Enzyme Solutions Formula 29 8 oz., lot 1225822 because of a labeling error at the manufacturing. This resulted in 10 jars incorrectly containing a Multiple Enzyme Powder. |
| OxyElite Pro Super Thermo Powder Green Apple (USPlabs) | F-1375-2014 | USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure. |
| OxyElite Pro Super Thermo Powder Fruit Punch (USPlabs) | F-1372-2014 | USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure. |
| OxyElite Pro Super Thermo (USPlabs) | F-1370-2014 | USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure. |
| OxyElite Pro Super Thermo (USPlabs) | F-1370-2014 | USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure. |
| Blood Sugar (Host Defense MycoBotanicals) | F-1231-2019 | Host Defense MycoBotanicals Blood Sugar, 60 ct. bottles, is recalled due to undeclared wheat. |
| Blood Sugar (Host Defense MycoBotanicals) | F-1231-2019 | Host Defense MycoBotanicals Blood Sugar, 60 ct. bottles, is recalled due to undeclared wheat. |
| Blood Sugar (Host Defense MycoBotanicals) | F-1231-2019 | Host Defense MycoBotanicals Blood Sugar, 60 ct. bottles, is recalled due to undeclared wheat. |
| 5-MTHF 1 mg (Kirkman) | F-1222-2024 | Labeling error. The 5-MTHF 1mg label incorrectly declares 5000mcg Folic Acid instead 1000mcg Folic Acid per serving in the Supplement Facts, but correctly declares Folate 1667mcg DFE. The front label correctly declares product as 5-MTHF Methyltetrahydrofolate 1mg (or 1000mcg). |
| Liquid Carnitine 1000 Lemon-Lime Flavor (Jarrow Formulas) | F-0682-2018 | A higher than normal micro result was found at the six month time point for one lot of Liquid L-Carnitine. |
| Liquid Carnitine Lemon-Lime Flavor (Jarrow Formulas) | F-0682-2018 | A higher than normal micro result was found at the six month time point for one lot of Liquid L-Carnitine. |
| Liquid Carnitine Lemon-Lime Flavor (Jarrow Formulas) | F-0682-2018 | A higher than normal micro result was found at the six month time point for one lot of Liquid L-Carnitine. |
| Liquid Carnitine Lemon-Lime Flavor (Jarrow Formulas) | F-0682-2018 | A higher than normal micro result was found at the six month time point for one lot of Liquid L-Carnitine. |
| Liquid Carnitine Lemon-Lime Flavor (Jarrow Formulas) | F-0682-2018 | A higher than normal micro result was found at the six month time point for one lot of Liquid L-Carnitine. |
| Bliss Anti-Stress Formula (Market America) | F-0681-2020 | Potentially undeclared Yohimbe 83 and complaints of adverse reactions: upset stomach, jittery, sweaty, lightheaded or dizzy. |
| Bliss (Market America) | F-0681-2020 | Potentially undeclared Yohimbe 83 and complaints of adverse reactions: upset stomach, jittery, sweaty, lightheaded or dizzy. |
| Vita Biotic 750 mg (Eclectic Herb) | F-0401-2025 | Product's ingredients names such as Oregon Grape, Cayenne Root, and Ginger Fruit and their quantities were not listed correctly in the Supplement Facts panel. |
| A.I. Enzymes (Pure Encapsulations) | F-0397-2018 | Product contains undeclared sulfites. |
| Tri-Vitamin Drops (Rugby) | F-0263-2017 | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. |
| Super Arthgold (Nanowellbeing Health) | D-1535-2014 | Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone. |
Most recent records
| Reported | Firm | Class | Product | Reason (FDA wording) |
|---|---|---|---|---|
| 2026-09-02 | ZMB Enterprises | Class I | Addall XR Shot 1 single bottle, 2 fl. oz., liquid dietary supplement | The product contains 1,4-DMAA, Phenylethylamine and Phenibut. H-1263-2026 |
| 2026-08-12 | FACTORY6, INC. | Class I | Zen Principle Naturals Moringa Leaf Powder dietary supplement, 900mg capsules, 180 capsules per PET white bottle. Intended Use: take 2 capsules per day. Route of Administration: OraI. Manufactured for | Possible Salmonella in Moringa Leaf Powder product. H-1222-2026 |
| 2026-08-05 | Mellish Island Corp | Class II | Mellish Island Super Skin; Dietary Supplement; 60 Capsules, 2 per day; Distributed by Mellish Island Corp. UPC: 8 58792 00332 3 | Firm's finished product label does not declare the source of marine collagen which was determined to be fish. H-1190-2026 |
| 2026-07-29 | Modern Warrior Life, LLC | Class I | Modern Warrior Ready, Dietary Supplement, 60 CAPSULES | FDA analysis revealed the presence of unapproved ingredients including tianeptine, 1,4 DMAA, and aniracetam. H-1178-2026 |
| 2026-07-08 | Provision Health Corp. dba PH Labs | Class II | Vista MAX; Dietary Supplement, 90 Capsules. Serving Size: 4 Capsules; Distributed by: Vision of Health, Bell, CA 90201 UPC: PHF-C023 | Dietary supplement product Vista MAX contains undeclared Yellow#5. H-1135-2026 |
| 2026-07-08 | Provision Health Corp. dba PH Labs | Class II | Ocular Plus with Lutein, Zeaxanthin, and Omega 3-6-9; Dietary Supplement, 200 Capsules. Serving Size: 4 Capsules; Distributed by: L.A. Farmacia Natural, Burbank, CA 91504 UPC: PHF-C023 | Dietary supplement product Ocular Plus contains undeclared Yellow#5. H-1134-2026 |
| 2026-06-17 | SENSORY SUPPLEMENT LLC | Class II | NEURO NOURISH dietary supplement; 6-IN-1 PREBIOTIC, PROBIOTIC, VITAMIN, MINERAL, FATTY ACID, AND ANTIOXIDANT NUTRITIONAL SUPPLEMENT TO SUPPORT DRAIN AND GUT HEALTH NET WT. 5.9 OZ; UPC: 310M5951601 | Premature lipid oxidation causing quality issue potentially causing product to have an off odor and bitter taste. H-1109-2026 |
| 2026-05-27 | Llorens Pharmaceuticals International Division, Inc. | Class II | Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement, Net Wt. 8 FL Oz (237mL) Amber PET modern round 24-400 bottle, 47 SERVING PER BOTTLE, 24 bottles- 8 FL Oz (237mL) Amber PET modern round bo | Foreign object: black particulate matter H-0809-2026 |
| 2026-05-27 | Safecor Health, LLC | Class II | Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. | Presence of a Foreign Substance; black particles observed in liquid D-0549-2026 |
| 2026-04-01 | Siluetaya, LLC | Class I | SiluetaYa Mexican Tejocote Roots Supplement Pieces; 7g/bottle; Dietary Supplement, UPC#: 7500464462411, Lot: US1220 " Expiration Date: 06/2027 | Product contains yellow oleander H-0647-2026 |
| 2026-03-25 | Shaman Botanicals, LLC | Class I | Product label reads in part as "WHITE VEIN ADVANCED ALKALOIDS CHEWABLE TABLETS 225mg 7-Hydroxymitragynine per container (7.5mg 7-OH per serving) LEMON DIETARY SUPPLEMENT Net Wt. 0.25 oz 30 TABLETS Sup | A sample of the product revealed the active ingredient is in a quantity greater than the labeled specification. H-1108-2026 |
| 2026-03-25 | Shaman Botanicals, LLC | Class I | Product label reads in part as "WHITE VEIN ADVANCED ALKALOIDS CHEWABLE TABLETS 15mg 7-Hydroxymitragynine per container (7.5mg 7-OH per serving) LEMON DIETARY SUPPLEMENT Net Wt. 0.02 oz 2 TABLETS Suppl | A sample of the product had the active ingredient in a quantity greater than the labeled specification. H-1107-2026 |
| 2026-03-18 | Ambrosia Brands LLC | Class I | Rosabella brand MORINGA; DIETARY SUPPLEMENT CAPSULES; 60 capsules per bottle; Distributed by: Ambrosia Brands, LLC, 625 Randall Ave, St. 100, Cheyenne, WY 82001; SUGGESTED USE: As a dietary supplement | Product may be contaminated with Salmonella H-0546-2026 |
| 2026-02-25 | Pure Solutions, Inc. | Class II | Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, Net Wt., 1 fl oz (30 ml) liquid dietary supplement, Glass bottle with dropper cap. (Individual 1 fl oz bottles (not sol | Label declares bovine colostrum but does not declare milk allergen. H-0537-2026 |
| 2026-02-18 | TKS Co-pack Manufacturing, LLC | Class II | Aonic Complete Hers. Dosage: Single serving liquid dietary supplement drink shot, 34 ml (1.1 Fl oz) in plastic bottle, induction sealed closed with plastic lid. Each bottle is a serving intended to be | Possible coliforms, E.coli, and/or Pseudomonas aeruginosa contamination. H-0520-2026 |
| 2026-02-18 | TKS Co-pack Manufacturing, LLC | Class II | Aonic Complete His. Dosage: Single serving liquid dietary supplement drink shot, 34 ml (1.1 Fl oz) in plastic bottle, induction sealed closed with plastic lid. Each bottle is a serving intended to be | Possible coliforms, E.coli, and/or Pseudomonas aeruginosa contamination. H-0521-2026 |
| 2026-02-11 | Imu-Tek Animal Health, Incorporated | Class II | Imu-Tek Immuno-5 Colostrum Powder 7 oz. Intended Use: Dietary Supplement for People. (Some customers use this for their pets).Packaging: Plastic jar with Sealed lid. Net Weight: 7 ounces. UPC:7 38654 | Undeclared milk allergen H-0483-2026 |
| 2026-02-04 | SUPERFOODS, INC. | Class I | Live it Up brand Super Greens; Chlorella, Spirulina, Wheatgrass, Kale, Broccoli, Spinach, Barley grass, Moringa, Parsley; Whole food dietary supplement powder; 30 day supply; NET WT. 8.5OZ (240G); Man | Products may be contaminated with Salmonella Typhimurium H-0433-2026 |
| 2026-02-04 | SUPERFOODS, INC. | Class I | a.) Live it Up brand Super Greens; Natural Wild Berry Flavor; Chlorella, Spirulina, Wheatgrass, Kale, Broccoli, Spinach, Barley grass, Moringa, Parsley; Whole food dietary supplement powder; 30 day su | Products may be contaminated with Salmonella Typhimurium H-0434-2026 |
| 2025-12-10 | Avion Pharmaceuticals, LLC | Class III | Prenate Chewable¿ A chewable Rx prenatal vitamin with a delicious chocolate flavor with Quatrefolic Dietary Supplement 30 Tablets Rx Only UPC 3 75854 30630 2 Manufactured for: Avion Pharmaceuticals, L | Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving. H-0233-2026 |
| 2025-12-10 | Water Pure, Inc. | Class II | My Bladder; Supports normal bladder tone & control; Dietary Supplement; packaged in white HDPE bottle with a white cap; bottle size is 150 CC; the net contents in 60 clear capsules containing brown po | Product may be contaminated with E. coli O7:K1 (IAI39/ExPEC) and E. coli 1303 H-0213-2026 |
| 2025-12-03 | MeriCal, LLC | Class I | Member's Mark Super Greens Dietary Supplement; 48 servings; Net Weight 18.28 oz (518.4g) UPC: 193968490775 | Potential contamination of Salmonella Richmond H-0205-2026 |
| 2025-10-15 | Organicare Nature's Science, LLC | Class II | FemiClear Daily Bladder Strength Dietary Supplement, 28 Count, UPC 817008020684, SKU FEM50060 | Microbial contamination with Escherichia coli O7:K1 and E. Coli 1303. H-0031-2026 |
| 2025-10-15 | M.O.M Enterprises, LLC. | Class II | Organic BABY bedtime drops; sleep + immunity blend; Promotes restful sleep with natural herbs & supports immunity with elderberry & vitamin C; LIQUID DIETARY SUPPLEMENT; AGE 4 MONTHS+, NET WT. 2 OZ (6 | Potential yeast contamination. H-0025-2026 |
| 2025-10-08 | Vitalabs, Inc. | Class II | vitamins B12 dietary supplement Raspberry Flavored sold under the following brand names: 1. Black Girl Vitamins 60 gummies UPC 8 60008 57505 0 Manufactured for: Black Girl Vitamins 601 W Harrison St., | Undeclared Peanuts. The firm was notified by their supplier, that the product may contain undeclared peanuts. H-0037-2026 |
All 684 records
| Reported | Firm | Class | Group | Reason (FDA wording) |
|---|---|---|---|---|
| 2026-09-02 | ZMB Enterprises | Class I | Undeclared drug ingredient | The product contains 1,4-DMAA, Phenylethylamine and Phenibut. H-1263-2026 |
| 2026-08-12 | FACTORY6, INC. | Class I | Microbial contamination | Possible Salmonella in Moringa Leaf Powder product. H-1222-2026 |
| 2026-08-05 | Mellish Island Corp | Class II | Other undeclared ingredient or label mismatch | Firm's finished product label does not declare the source of marine collagen which was determined to be fish. H-1190-2026 |
| 2026-07-29 | Modern Warrior Life, LLC | Class I | Undeclared drug ingredient | FDA analysis revealed the presence of unapproved ingredients including tianeptine, 1,4 DMAA, and aniracetam. H-1178-2026 |
| 2026-07-08 | Provision Health Corp. dba PH Labs | Class II | Other undeclared ingredient or label mismatch | Dietary supplement product Vista MAX contains undeclared Yellow#5. H-1135-2026 |
| 2026-07-08 | Provision Health Corp. dba PH Labs | Class II | Other undeclared ingredient or label mismatch | Dietary supplement product Ocular Plus contains undeclared Yellow#5. H-1134-2026 |
| 2026-06-17 | SENSORY SUPPLEMENT LLC | Class II | Potency, dissolution or quality defect | Premature lipid oxidation causing quality issue potentially causing product to have an off odor and bitter taste. H-1109-2026 |
| 2026-05-27 | Llorens Pharmaceuticals International Division, Inc. | Class II | Contaminants, adulteration or foreign material | Foreign object: black particulate matter H-0809-2026 |
| 2026-05-27 | Safecor Health, LLC | Class II | Contaminants, adulteration or foreign material | Presence of a Foreign Substance; black particles observed in liquid D-0549-2026 |
| 2026-04-01 | Siluetaya, LLC | Class I | Contaminants, adulteration or foreign material | Product contains yellow oleander H-0647-2026 |
| 2026-03-25 | Shaman Botanicals, LLC | Class I | Labeling, manufacturing, potency or other | A sample of the product revealed the active ingredient is in a quantity greater than the labeled specification. H-1108-2026 |
| 2026-03-25 | Shaman Botanicals, LLC | Class I | Labeling, manufacturing, potency or other | A sample of the product had the active ingredient in a quantity greater than the labeled specification. H-1107-2026 |
| 2026-03-18 | Ambrosia Brands LLC | Class I | Microbial contamination | Product may be contaminated with Salmonella H-0546-2026 |
| 2026-02-25 | Pure Solutions, Inc. | Class II | Undeclared allergen | Label declares bovine colostrum but does not declare milk allergen. H-0537-2026 |
| 2026-02-18 | TKS Co-pack Manufacturing, LLC | Class II | Microbial contamination | Possible coliforms, E.coli, and/or Pseudomonas aeruginosa contamination. H-0520-2026 |
| 2026-02-18 | TKS Co-pack Manufacturing, LLC | Class II | Microbial contamination | Possible coliforms, E.coli, and/or Pseudomonas aeruginosa contamination. H-0521-2026 |
| 2026-02-11 | Imu-Tek Animal Health, Incorporated | Class II | Undeclared allergen | Undeclared milk allergen H-0483-2026 |
| 2026-02-04 | SUPERFOODS, INC. | Class I | Microbial contamination | Products may be contaminated with Salmonella Typhimurium H-0433-2026 |
| 2026-02-04 | SUPERFOODS, INC. | Class I | Microbial contamination | Products may be contaminated with Salmonella Typhimurium H-0434-2026 |
| 2025-12-10 | Avion Pharmaceuticals, LLC | Class III | Undeclared allergen | Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving. H-0233-2026 |
| 2025-12-10 | Water Pure, Inc. | Class II | Microbial contamination | Product may be contaminated with E. coli O7:K1 (IAI39/ExPEC) and E. coli 1303 H-0213-2026 |
| 2025-12-03 | MeriCal, LLC | Class I | Microbial contamination | Potential contamination of Salmonella Richmond H-0205-2026 |
| 2025-10-15 | Organicare Nature's Science, LLC | Class II | Microbial contamination | Microbial contamination with Escherichia coli O7:K1 and E. Coli 1303. H-0031-2026 |
| 2025-10-15 | M.O.M Enterprises, LLC. | Class II | Microbial contamination | Potential yeast contamination. H-0025-2026 |
| 2025-10-08 | Vitalabs, Inc. | Class II | Undeclared allergen | Undeclared Peanuts. The firm was notified by their supplier, that the product may contain undeclared peanuts. H-0037-2026 |
| 2025-10-01 | Extract Labs, Inc. | Class II | Labeling, manufacturing, potency or other | Potential peanut protein cross-contact. H-0623-2025 |
| 2025-10-01 | Extract Labs, Inc. | Class II | Labeling, manufacturing, potency or other | Potential peanut protein cross-contact. H-0621-2025 |
| 2025-10-01 | Extract Labs, Inc. | Class II | Labeling, manufacturing, potency or other | Potential peanut protein cross-contact. H-0622-2025 |
| 2025-10-01 | Extract Labs, Inc. | Class II | Labeling, manufacturing, potency or other | Potential peanut protein cross-contact. H-0624-2025 |
| 2025-09-24 | Hi-Tech Pharmaceuticals Inc. | Class III | Unapproved drug claims or misbranding | Unapproved Drug Claims and Misbranded. H-0598-2025 |
| 2025-09-24 | Hi-Tech Pharmaceuticals Inc. | Class III | Unapproved drug claims or misbranding | Unapproved Drug Claims. H-0599-2025 |
| 2025-09-24 | Hi-Tech Pharmaceuticals Inc. | Class III | Unapproved drug claims or misbranding | Unapproved Drug Claims and Misbranded. H-0592-2025 |
| 2025-09-24 | Hi-Tech Pharmaceuticals Inc. | Class III | Unapproved drug claims or misbranding | Unapproved Drug Claims and Misbranded. H-0594-2025 |
| 2025-09-24 | Hi-Tech Pharmaceuticals Inc. | Class III | Unapproved drug claims or misbranding | Unapproved Drug Claims. H-0591-2025 |
| 2025-09-24 | Hi-Tech Pharmaceuticals Inc. | Class III | Unapproved drug claims or misbranding | Unapproved Drug Claims and Misbranded. H-0600-2025 |
| 2025-09-24 | Hi-Tech Pharmaceuticals Inc. | Class III | Unapproved drug claims or misbranding | Unapproved Drug Claims. H-0595-2025 |
| 2025-09-24 | Hi-Tech Pharmaceuticals Inc. | Class III | Unapproved drug claims or misbranding | Unapproved Drug Claims and Misbranded. H-0601-2025 |
| 2025-09-24 | Hi-Tech Pharmaceuticals Inc. | Class III | Unapproved drug claims or misbranding | Unapproved Drug Claims and Misbranded. H-0597-2025 |
| 2025-09-24 | Hi-Tech Pharmaceuticals Inc. | Class III | Unapproved drug claims or misbranding | Unapproved Drug Claims. H-0596-2025 |
| 2025-09-24 | Hi-Tech Pharmaceuticals Inc. | Class III | Unapproved drug claims or misbranding | Unapproved Drug Claims. H-0590-2025 |
| 2025-09-24 | Hi-Tech Pharmaceuticals Inc. | Class III | Unapproved drug claims or misbranding | Unapproved Drug Claims and Misbranded. H-0593-2025 |
| 2025-09-17 | M.O.M Enterprises, LLC. | Class II | Microbial contamination | Potential for spoilage due to yeast contamination. H-0576-2025 |
| 2025-09-17 | Dynamic Sports Nutrition | Class III | Potency, dissolution or quality defect | Dietary supplement involved degradation of an ingredient. Product is sub-potent for Vitamin B12 not meeting label claims. H-0573-2025 |
| 2025-08-20 | GMP Laboratories of America Inc | Class III | Potency, dissolution or quality defect | Downstream recall of a dietary supplement ingredient that was manufactured out of specification. H-0448-2025 |
| 2025-08-20 | GMP Laboratories of America Inc | Class III | Potency, dissolution or quality defect | Downstream recall of a dietary supplement ingredient that was manufactured out of specifications. H-0447-2025 |
| 2025-07-02 | Preventics, Inc. dba Legere Pharmaceuticals | Class III | Other undeclared ingredient or label mismatch | Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules. H-0096-2025 |
| 2025-07-02 | Preventics, Inc. dba Legere Pharmaceuticals | Class III | Other undeclared ingredient or label mismatch | Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules. H-0091-2025 |
| 2025-07-02 | Preventics, Inc. dba Legere Pharmaceuticals | Class III | Other undeclared ingredient or label mismatch | Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules. H-0094-2025 |
| 2025-07-02 | Preventics, Inc. dba Legere Pharmaceuticals | Class III | Other undeclared ingredient or label mismatch | Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules. H-0092-2025 |
| 2025-07-02 | Preventics, Inc. dba Legere Pharmaceuticals | Class III | Other undeclared ingredient or label mismatch | Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules. H-0095-2025 |
| 2025-07-02 | Preventics, Inc. dba Legere Pharmaceuticals | Class III | Other undeclared ingredient or label mismatch | Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules. H-0093-2025 |
| 2025-06-18 | SAINI TRADE INC | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil. D-0465-2025 |
| 2025-06-18 | SAINI TRADE INC | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. D-0466-2025 |
| 2025-06-18 | SAINI TRADE INC | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. D-0464-2025 |
| 2025-06-18 | SAINI TRADE INC | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil. D-0463-2025 |
| 2025-04-30 | Supplement Manufacturing Partner Inc. | Class I | Undeclared allergen | Undeclared allergen: Wheat F-0729-2025 |
| 2025-04-16 | MTN OPS, LLC | Class II | Undeclared allergen | Undeclared soy flour F-0698-2025 |
| 2025-04-09 | Bioriginal Food & Science Corporation | Class II | Undeclared allergen | Undeclared allergens: Soy lecithin F-0709-2025 |
| 2025-04-02 | Veridance Pharmacal, LLC | Class II | Labeling, manufacturing, potency or other | Levels of iodine exceeding label claim F-0671-2025 |
| 2025-03-26 | One Source Nutrition, Inc, | Class I | Undeclared drug ingredient | Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil. D-0281-2025 |
| 2025-01-22 | Eclectic Institute Inc | Class III | Other undeclared ingredient or label mismatch | Product's ingredients names such as Oregon Grape, Cayenne Root, and Ginger Fruit and their quantities were not listed correctly in the Supplement Facts panel. F-0401-2025 |
| 2025-01-01 | Zoe US, Inc. | Class II | Contaminants, adulteration or foreign material | Product may contain foreign objects: small metal pieces and/or stones F-0316-2025 |
| 2024-12-18 | Deseret Biologicals Inc | Class II | Undeclared allergen | Product contains undeclared soy lecithin. F-0262-2025 |
| 2024-11-27 | Nestle Product Technology Center - Nestle Health Science | Class II | Contaminants, adulteration or foreign material | Nestle Health Science (NHS U.S., LLC) is initiating a recall of Douglas Labs Stress-B-Plus Dietary Supplement Tablets, 90 tablets per bottle. The bottle is white and made of plastic. Lot Numbers 50335944,50344396, expiration date 04/11/2026. The product is being recalled because of Incorrect formulation manufactured vs F-0139-2025 |
| 2024-10-23 | Gorilla Mind LLC | Class I | Microbial contamination | Product was recalled due to the potential for contamination with Salmonella F-0053-2025 |
| 2024-10-02 | Guru Inc. | Class II | Undeclared drug ingredient | Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone. D-0666-2024 |
| 2024-07-10 | Grato Holdings, Inc. | Class II | Microbial contamination | Potential microbial contamination (yeast and/or mold). F-1458-2024 |
| 2024-07-10 | Integrity Products | Class I | Undeclared drug ingredient | Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil. D-0585-2024 |
| 2024-05-22 | Stop Clopez Corp | Class I | Labeling, manufacturing, potency or other | Marketed Without An Approved NDA/ANDA D-0494-2024 |
| 2024-05-15 | HTO Nevada Inc DBA Kirkman | Class III | Labeling, manufacturing, potency or other | Labeling error. The 5-MTHF 1mg label incorrectly declares 5000mcg Folic Acid instead 1000mcg Folic Acid per serving in the Supplement Facts, but correctly declares Folate 1667mcg DFE. The front label correctly declares product as 5-MTHF Methyltetrahydrofolate 1mg (or 1000mcg). F-1222-2024 |
| 2024-04-24 | HandNatural | Class I | Contaminants, adulteration or foreign material | Product is being recalled due to the presence of yellow oleander and its components in the product. F-1158-2024 |
| 2024-04-03 | Nordic Naturals, Inc. | Class II | Labeling, manufacturing, potency or other | Elevated levels of vitamin D3 F-1109-2024 |
| 2024-04-03 | VRA FORMULATIONS LLC | Class III | Potency, dissolution or quality defect | Due to sub-potent levels of Zinc F-1125-2024 |
| 2024-03-06 | Ancient Formulas, Inc. | Class III | Potency, dissolution or quality defect | Product is sub-potent for Vitamin D and label contains incorrect percent daily value. F-0930-2024 |
| 2024-02-28 | Today The World | Class I | Undeclared drug ingredient | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug. D-0345-2024 |
| 2024-02-28 | Today The World | Class I | Undeclared drug ingredient | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug. D-0344-2024 |
| 2024-02-28 | Today The World | Class I | Undeclared drug ingredient | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug. D-0343-2024 |
| 2024-01-10 | BioMylz Pvt. Ltd. | Class II | Microbial contamination | Potential mold contamination F-0664-2024 |
| 2023-12-13 | Garden Of Life Llc | Class II | Undeclared allergen | Undeclared Soy. F-0484-2024 |
| 2023-12-13 | Garden Of Life Llc | Class II | Undeclared allergen | Undeclared Soy. F-0482-2024 |
| 2023-12-13 | Garden Of Life Llc | Class II | Undeclared allergen | Undeclared Soy. F-0483-2024 |
| 2023-12-13 | SUGARMDS LLC | Class I | Undeclared drug ingredient | MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide D-0138-2024 |
| 2023-11-29 | ActiPharma, Inc. | Class III | Labeling, manufacturing, potency or other | FDA sample analysis of ACTIRON Dietary Supplement, 100 Tablets, Lot 13309, found the product did not meet folic acid specification compared to the label claim. F-0463-2024 |
| 2023-11-15 | Kula Brands LLC | Class I | Undeclared allergen | Undeclared Allergens: Milk and Tree Nut (Coconut) and Unapproved Food Additive: Kratom F-0320-2024 |
| 2023-11-08 | Select Custom Solutions, LLC | Class II | Contaminants, adulteration or foreign material | foreign material - plastic F-0313-2024 |
| 2023-10-04 | Pharma-Natural Inc. | Class III | Labeling, manufacturing, potency or other | FDA sample analysis of Pharma Natural Biotin 5000 mcg Maximum Strength (30 tablets, Lot: PN10686, Exp. Date 01/24), found the biotin content was below the detection limit. F-1615-2023 |
| 2023-08-02 | Emceta International Inc. | Class III | Labeling, manufacturing, potency or other | FDA sample analysis of Natural Systems brand Multi Vitamin, 60 Tablets, found the magnesium content as 33.5% of the amount declared in label. F-1295-2023 |
| 2023-08-02 | Emceta International Inc. | Class III | Manufacturing practice (cGMP) or consent decree | FDA evaluation of Natural Systems brand HAIR - SKIN NAIL Dietary Supplement label disclosed several deficiencies to 21 CFR 101 Labeling Regulations. F-1296-2023 |
| 2023-06-14 | Procaps S.A. de C.V. | Class II | Other undeclared ingredient or label mismatch | PEG-40 not declared as an ingredient on the label F-0978-2023 |
| 2023-05-24 | Big Bold Health Holdings Inc | Class II | Contaminants, adulteration or foreign material | Glass fragments. F-0886-2023 |
| 2023-05-17 | FLP LLC | Class II | Other undeclared ingredient or label mismatch | Colostrum is declared but label does not declare milk. F-0822-2023 |
| 2023-05-10 | Novis PR, LLC dba Kramer Novis | Class II | Labeling, manufacturing, potency or other | Bloated Protein Bottle F-0810-2023 |
| 2023-05-10 | Novis PR, LLC dba Kramer Novis | Class II | Labeling, manufacturing, potency or other | Bloated Protein Bottle F-0811-2023 |
| 2023-05-10 | Novis PR, LLC dba Kramer Novis | Class II | Labeling, manufacturing, potency or other | Bloated Protein Bottle F-0812-2023 |
| 2023-04-26 | Natural Solutions Foundation | Class II | Labeling, manufacturing, potency or other | Product labeled and intended to mitigate, prevent, or treat COVID-19 F-0733-2023 |
| 2023-03-22 | Mason Vitamins, Inc. | Class III | Potency, dissolution or quality defect | Product is sub-potent for Vitamins A, B12, B5 (Pantothenic acid), C, and E not meeting label claims. F-0424-2023 |
| 2023-03-22 | Mason Vitamins, Inc. | Class III | Potency, dissolution or quality defect | Product is sub-potent for Vitamins A, B12, B5 (Pantothenic acid), C, and E not meeting label claims. F-0425-2023 |
| 2023-02-15 | Ortho Molecular Products, Inc. | Class II | Microbial contamination | Raw material tested positive for Cronobacter sakazakii. F-0340-2023 |
| 2023-02-08 | Professional Complementary Health Formulas, LLC | Class II | Other undeclared ingredient or label mismatch | Product recalled due to undeclared niacin. F-0322-2023 |
| 2023-02-08 | Professional Complementary Health Formulas, LLC | Class II | Other undeclared ingredient or label mismatch | Product recalled due to undeclared niacin. F-0323-2023 |
| 2022-10-26 | Seeking Health LLC | Class II | Labeling, manufacturing, potency or other | The product label claim for copper is 0.5mg, but third-party lab results revealed product contains higher levels of copper. F-0048-2023 |
| 2022-10-26 | BEST NUTRITIONALS LLC | Class I | Microbial contamination | Best Nutritionals LLC 120 Centennial Ave, Piscataway NJ 08854, is initiating a recall of Fenugreek 610 mg , 360 Capsules ,in White Plastic HDPE bottles because the product has the potential to be contaminated with Salmonella. F-0080-2023 |
| 2022-10-19 | Novis PR, LLC dba Kramer Novis | Class III | Potency, dissolution or quality defect | Physical appearance of bottle of G-Pre Protein was atypical. Once opened, unusual odor was noticed and atypical bubbles were present. F-0037-2023 |
| 2022-10-12 | Eden's Answers Inc | Class II | Microbial contamination | High bacterial growth within products F-0031-2023 |
| 2022-10-12 | Eden's Answers Inc | Class II | Microbial contamination | High bacterial growth within products F-0032-2023 |
| 2022-10-12 | Eden's Answers Inc | Class II | Microbial contamination | High bacterial growth within products F-0030-2023 |
| 2022-07-27 | Loud Muscle Science | Class I | Undeclared drug ingredient | Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. D-1336-2022 |
| 2022-07-27 | Loud Muscle Science | Class II | Unapproved drug claims or misbranding | Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims. D-1339-2022 |
| 2022-07-20 | Premier Research Labs LLC | Class II | Labeling, manufacturing, potency or other | Product spoiling over time; spoilage visible beneath lid/closure upon opening. F-1418-2022 |
| 2022-04-20 | Bio-Botanica, Inc. | Class II | Labeling, manufacturing, potency or other | Product contained cesium chloride, a New Dietary Ingredient F-1000-2022 |
| 2022-02-02 | World Health Products LLC | Class II | Undeclared allergen | Product may contain undeclared milk. F-0522-2022 |
| 2022-01-19 | NutraCap Labs LLC | Class II | Other undeclared ingredient or label mismatch | During an FDA investigation the firm was notified that the product contains undeclared coconut. F-0399-2022 |
| 2021-12-29 | Golden Lab LLC | Class II | Undeclared allergen | Undeclared fish allergen F-0352-2022 |
| 2021-12-01 | MARY RUTH ORGANICS | Class I | Microbial contamination | Internal testing found the presence of Pseudomonas aeruginosa in the product. F-0214-2022 |
| 2021-11-10 | Health & Wellness Center, Inc. | Class II | Microbial contamination | Product recalled because of the presence of mold and/or yeast found in amounts that exceed the product's established specifications . F-0092-2022 |
| 2021-11-10 | NSE Products, Inc. | Class II | Undeclared allergen | Pharmanex Jungamals was found to have a missing fish allergen statement on the label due to fish gelatin as a sub-component of the Vitamin E ingredient. F-0095-2022 |
| 2021-10-13 | BRAINMD | Class II | Labeling, manufacturing, potency or other | It was discovered that bottles of Brain and Memory Power Boost was filled with multi vitamin-mineral product - NeuroVite Plus F-0010-2022 |
| 2021-10-06 | Monarch PCM, LLC | Class II | Potency, dissolution or quality defect | Stability is out of spec at 81% for 3 month time period. F-1020-2021 |
| 2021-09-01 | New Dawn Nutrition, Inc. | Class II | Undeclared allergen | Product contained undeclared milk, wheat, and soy. F-0886-2021 |
| 2021-08-18 | IHERB LLC | Class I | Undeclared allergen | Informed by contract manufacturer that the MCT ingredient used in their product was under recall due to undeclared milk. F-0846-2021 |
| 2021-08-18 | Slayer Forever, LLC dba BUBS Naturals | Class I | Undeclared allergen | Firm was notified by supplier of Medium Chain Triglycerides (MCT) that it contained undeclared milk allergens. F-0847-2021 |
| 2021-08-11 | Bomunity Ltd Co | Class II | Microbial contamination | Potential to be contaminated with bacteria F-0817-2021 |
| 2021-07-21 | Bea Lydeckers Naturals Inc | Class II | Other undeclared ingredient or label mismatch | Label declares lecithin but does not declare soy lecithin. F-0778-2021 |
| 2021-07-21 | Bea Lydeckers Naturals Inc | Class II | Other undeclared ingredient or label mismatch | Label declares lecithin but does not declare soy lecithin. F-0780-2021 |
| 2021-07-21 | Bea Lydeckers Naturals Inc | Class II | Other undeclared ingredient or label mismatch | Label declares lecithin but does not declare soy lecithin. F-0779-2021 |
| 2021-07-21 | Bea Lydeckers Naturals Inc | Class II | Other undeclared ingredient or label mismatch | Label declares lecithin but does not declare soy lecithin. F-0777-2021 |
| 2021-06-23 | Lopez Gonzalez Santana Corporation | Class III | Manufacturing practice (cGMP) or consent decree | CGMP Deviations: Presence of damaged tablets F-0665-2021 |
| 2021-06-23 | Lopez Gonzalez Santana Corporation | Class III | Manufacturing practice (cGMP) or consent decree | CGMP Deviations: Presence of damaged tablets F-0666-2021 |
| 2021-06-09 | Garry N Sun USA Inc. | Class I | Contaminants, adulteration or foreign material | State of Iowa collected consumer sample and found high levels of lead - 12,200 mg/kg F-0633-2021 |
| 2021-06-02 | Cardinal Health Inc. | Class II | Manufacturing practice (cGMP) or consent decree | CGMP Deviations: Intermittent exposure to temperature excursion during storage. D-0467-2021 |
| 2021-06-02 | Cardinal Health Inc. | Class II | Manufacturing practice (cGMP) or consent decree | CGMP Deviations: Intermittent exposure to temperature excursion during storage. D-0531-2021 |
| 2021-06-02 | Cardinal Health Inc. | Class II | Manufacturing practice (cGMP) or consent decree | CGMP Deviations: Intermittent exposure to temperature excursion during storage. D-0532-2021 |
| 2021-06-02 | Cardinal Health Inc. | Class II | Manufacturing practice (cGMP) or consent decree | CGMP Deviations: Intermittent exposure to temperature excursion during storage. D-0488-2021 |
| 2021-06-02 | Cardinal Health Inc. | Class II | Manufacturing practice (cGMP) or consent decree | CGMP Deviations: Intermittent exposure to temperature excursion during storage. D-0475-2021 |
| 2021-06-02 | Cardinal Health Inc. | Class II | Manufacturing practice (cGMP) or consent decree | CGMP Deviations: Intermittent exposure to temperature excursion during storage. D-0587-2021 |
| 2021-05-26 | Hi Tech Pharmaceuticals | Class I | Undeclared allergen | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. F-0502-2021 |
| 2021-05-26 | Hi Tech Pharmaceuticals | Class I | Undeclared allergen | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. F-0500-2021 |
| 2021-05-26 | PUBLIC GOODS | Class II | Undeclared allergen | Product may contain undeclared soy. F-0494-2021 |
| 2021-05-26 | Hi Tech Pharmaceuticals | Class I | Undeclared allergen | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. F-0499-2021 |
| 2021-05-26 | Hi Tech Pharmaceuticals | Class I | Undeclared allergen | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. F-0498-2021 |
| 2021-05-26 | Hi Tech Pharmaceuticals | Class I | Undeclared allergen | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. F-0503-2021 |
| 2021-05-26 | Hi Tech Pharmaceuticals | Class I | Undeclared allergen | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. F-0509-2021 |
| 2021-05-26 | Hi Tech Pharmaceuticals | Class I | Undeclared allergen | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. F-0506-2021 |
| 2021-05-26 | Hi Tech Pharmaceuticals | Class I | Undeclared allergen | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. F-0505-2021 |
| 2021-05-26 | Lopez Gonzalez Santana Corporation | Class III | Manufacturing practice (cGMP) or consent decree | CGMP Deviations: Presence of damaged tablets F-0540-2021 |
| 2021-05-26 | Hi Tech Pharmaceuticals | Class I | Undeclared allergen | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. F-0504-2021 |
| 2021-05-26 | Hi Tech Pharmaceuticals | Class I | Undeclared allergen | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. F-0501-2021 |
| 2021-05-26 | Hi Tech Pharmaceuticals | Class I | Undeclared allergen | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. F-0507-2021 |
| 2021-05-26 | Hi Tech Pharmaceuticals | Class I | Undeclared allergen | During an inspection by the FDA the firm was notified by FDA that the product contains undeclared milk, wheat & soy. F-0508-2021 |
| 2021-05-26 | Lopez Gonzalez Santana Corporation | Class III | Manufacturing practice (cGMP) or consent decree | CGMP Deviations: Presence of damaged tablets F-0541-2021 |
| 2021-05-19 | Lopez Gonzalez Santana Corporation | Class III | Manufacturing practice (cGMP) or consent decree | cGMP Deviation: Presence of damaged tablets F-0484-2021 |
| 2020-12-23 | Fusion Health and Vitality LLC | Class II | Unapproved drug claims or misbranding | The firm is recalling their products due the unapproved use of a food additive and unapproved marketing statements F-0180-2021 |
| 2020-12-09 | Quantum Inc | Class I | Microbial contamination | Product recalled due to potential contamination of Salmonella. F-0146-2021 |
| 2020-08-19 | Wellements LLC | Class I | Undeclared allergen | Product contains undeclared milk F-1147-2020 |
| 2020-08-19 | Upspring,ltd | Class I | Undeclared allergen | May contain undeclared milk F-1149-2020 |
| 2020-08-19 | Wellements LLC | Class I | Undeclared allergen | Product contains undeclared milk F-1148-2020 |
| 2020-07-22 | GOLDEN NUTRITION INC | Class II | Unapproved drug claims or misbranding | The product is a dietary supplement with drug claims (COVID-19) F-1028-2020 |
| 2020-05-06 | GOLDEN NUTRITION INC | Class III | Labeling, manufacturing, potency or other | FDA sample analysis of Biotin 1000mg Lot #1345 showed the product Biotin content to be 0.8% of label claim. F-0930-2020 |
| 2020-05-06 | Alfa Vitamins Laboratories, Inc. | Class III | Labeling, manufacturing, potency or other | FDA sample analysis of Calci-Max lot 31453 showed the product zinc content to be 0.0% of label claim. F-0926-2020 |
| 2020-04-22 | CT Health Solutions, LLC | Class III | Potency, dissolution or quality defect | Due to different color of powder in capsules. Firm's evaluation determined product low potency. F-0923-2020 |
| 2020-04-08 | National Vitamin Company Inc | Class III | Labeling, manufacturing, potency or other | Customer reports of label error. Front panel states strength of 1000 mg although supplement fact is correct in stating 1000 mcg. F-0872-2020 |
| 2020-04-08 | Y-O Management LLC, dba Natural Remedy Store | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction D-1080-2020 |
| 2020-04-01 | Organic By Nature, Inc. | Class III | Unapproved drug claims or misbranding | Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop F-0906-2020 |
| 2020-04-01 | Organic By Nature, Inc. | Class III | Unapproved drug claims or misbranding | Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop F-0903-2020 |
| 2020-04-01 | Organic By Nature, Inc. | Class III | Unapproved drug claims or misbranding | Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop F-0895-2020 |
| 2020-04-01 | Organic By Nature, Inc. | Class III | Unapproved drug claims or misbranding | Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop F-0902-2020 |
| 2020-04-01 | Organic By Nature, Inc. | Class III | Unapproved drug claims or misbranding | Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop F-0905-2020 |
| 2020-03-25 | Med Man Distribution, Inc. | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis. D-1037-2020 |
| 2020-03-25 | Med Man Distribution, Inc. | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis. D-1036-2020 |
| 2020-03-04 | Pro-Form Manufacturing LLC | Class III | Unapproved drug claims or misbranding | Notified by supplier that flax seed used in products is under recall due to detection of unapproved herbicide. F-0783-2020 |
| 2020-03-04 | Pro-Form Manufacturing LLC | Class III | Unapproved drug claims or misbranding | Notified by supplier that flax seed used in products is under recall due to detection of unapproved herbicide. F-0784-2020 |
| 2020-02-26 | Green Water, LLC | Class II | Labeling, manufacturing, potency or other | The products contain Coltsfoot, which is not to be used internally. F-0707-2020 |
| 2020-02-26 | Green Water, LLC | Class II | Labeling, manufacturing, potency or other | The products contain Coltsfoot, which is not to be used internally. F-0708-2020 |
| 2020-02-26 | ABH Nature's Products, Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Firm ordered by consent decree to recall all products because the products were prepared, packed, or held in violation of current good manufacturing practice regulation (cGMP). F-0705-2020 |
| 2020-02-19 | Market America Inc | Class II | Other undeclared ingredient or label mismatch | Potentially undeclared Yohimbe 83 and complaints of adverse reactions: upset stomach, jittery, sweaty, lightheaded or dizzy. F-0681-2020 |
| 2020-02-12 | Merical, LLC | Class II | Undeclared allergen | Product label does not contain Crustacean Shellfish on the ingredient list or allergen information F-0632-2020 |
| 2020-02-05 | Kindroot LLC | Class II | Labeling, manufacturing, potency or other | Inspection by California Department of Public Health found that product label did not include fish as the source of collagen peptides. F-0573-2020 |
| 2019-11-27 | Basic Reset Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Products do not conform to Dietary Supplement CGMP regulations. F-0171-2020 |
| 2019-11-27 | Basic Reset Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Products do not conform to Dietary Supplement CGMP regulations. F-0170-2020 |
| 2019-10-30 | Threshold Enterprises Ltd | Class III | Labeling, manufacturing, potency or other | Labeling error; incorrect supplement facts panel and label claims for two ingredients were lower than the product formulation. F-0061-2020 |
| 2019-10-30 | HP Ingredients | Class III | Labeling, manufacturing, potency or other | Calcium Complex label does not bear a "Contains: milk" advisory in the correct format. F-0069-2020 |
| 2019-09-18 | Jivan Shakti Inc. | Class III | Labeling, manufacturing, potency or other | Product label declares Vitamin D3 at 200 IU per serving. FDA sample analysis revealed no Vitamin D in product. F-2144-2019 |
| 2019-07-31 | Nexagen, LLC | Class II | Labeling, manufacturing, potency or other | Product contains insufficient Higenamine and the label incorrectly declares Cayenne Pepper (CapsiMax) and Choline Bitartrate. F-1942-2019 |
| 2019-07-03 | BioDose Pharma, LLC | Class II | Microbial contamination | Product has potential to be contaminated with Bacillus cepacia. F-1487-2019 |
| 2019-05-01 | Mineralife LLC | Class II | Microbial contamination | The dietary supplement product is potentially contaminated with Pseudomonas aeruginosa F-1305-2019 |
| 2019-04-24 | Cays LLC | Class II | Other undeclared ingredient or label mismatch | Undeclared coating ingredients: HPMC, Triacetin, Titanium Dioxide, FD & C Yellow # 5, FD & C Yellow # 6, FD & C Blue # 1. In addition, the label states Silicon Dioxide, which is not part of the formulation F-1295-2019 |
| 2019-04-17 | Merical, LLC | Class III | Labeling, manufacturing, potency or other | Incorrect probiotic strain used in formulation which did not match product labeling. F-1275-2019 |
| 2019-04-17 | McDaniel Life-Line LLC | Class II | Unapproved drug claims or misbranding | Unapproved new drug D-1111-2019 |
| 2019-04-10 | Fungi Perfecti LLC | Class II | Undeclared allergen | Host Defense MycoBotanicals Blood Sugar, 60 ct. bottles, is recalled due to undeclared wheat. F-1231-2019 |
| 2019-03-13 | Kingston Pharma LLC | Class I | Labeling, manufacturing, potency or other | Presence of an undissolved ingredient, citrus flavonoid. F-1171-2019 |
| 2019-03-13 | Twenty-First Century Healthcare, Inc | Class III | Other undeclared ingredient or label mismatch | 21st Century HealthCare, Inc. is recalling Good Neighbor Pharmacy brand Co Q10 200mg 30ct capsules due the product being mislabeled and potentially containing Vit D 2000 IU. F-1146-2019 |
| 2019-03-13 | Twenty-First Century Healthcare, Inc | Class III | Other undeclared ingredient or label mismatch | 21st Century HealthCare, Inc. is recalling Good Neighbor Pharmacy brand Co Q10 200mg 30ct capsules due the product being mislabeled and potentially containing Vit D 2000 IU. F-1147-2019 |
| 2019-02-27 | Nutrafuels, Inc. | Class II | Microbial contamination | Recalling firm's consignee conducted third party micro testing showing microbial contamination in specific lots of the following products: CTFO Sleep Support Oral Spray (Aspergillus), CTFO Pain Relief Oral Spray (total aerobic bacteria), and CTFO Weight Loss Oral Spray (Enterobacteriaceae). F-1046-2019 |
| 2019-02-27 | Nutrafuels, Inc. | Class II | Microbial contamination | Recalling firm's consignee conducted third party micro testing showing microbial contamination in specific lots of the following products: CTFO Sleep Support Oral Spray (Aspergillus), CTFO Pain Relief Oral Spray (total aerobic bacteria), and CTFO Weight Loss Oral Spray (Enterobacteriaceae). F-1045-2019 |
| 2019-02-27 | Nutrafuels, Inc. | Class II | Microbial contamination | Recalling firm's consignee conducted third party micro testing showing microbial contamination in specific lots of the following products: CTFO Sleep Support Oral Spray (Aspergillus), CTFO Pain Relief Oral Spray (total aerobic bacteria), and CTFO Weight Loss Oral Spray (Enterobacteriaceae). F-1047-2019 |
| 2018-12-12 | Agropur MSI Ingredients LLC | Class I | Undeclared allergen | JayRobb Unflavored Egg White Protein Product is being recalled due to undeclared milk. F-0717-2019 |
| 2018-11-21 | Zero Xtreme USA | Class II | Undeclared drug ingredient | Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine D-0246-2019 |
| 2018-10-10 | Church & Dwight Co | Class II | Unapproved drug claims or misbranding | Product is misbranded. Bottles contain another product -GABA Calm Sublingual Orange tablets. F-1992-2018 |
| 2018-10-03 | Zakah Life LLC | Class I | Microbial contamination | The firm distributes dietary supplements which contain Mitragyna speciosa (kratom) a dietary ingredient with inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Also, based on FDA sample positive sample results, the red an F-1983-2018 |
| 2018-10-03 | Confidence Inc./Confidence U.S.A. Inc. | Class III | Other undeclared ingredient or label mismatch | Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol (PEG). F-1971-2018 |
| 2018-10-03 | Confidence Inc./Confidence U.S.A. Inc. | Class II | Other undeclared ingredient or label mismatch | Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol (PEG), Triacetin, FD&C Yellow #6 (Sunset Yellow FCF), FD&C Red #40 (Allura Red AC), FD&C Blue #1 (Aluminum Lake). F-1972-2018 |
| 2018-10-03 | Zakah Life LLC | Class I | Microbial contamination | The firm distributes dietary supplements which contain Mitragyna speciosa (kratom) a dietary ingredient with inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Also, based on FDA sample positive sample results, the red an F-1982-2018 |
| 2018-10-03 | Zakah Life LLC | Class II | Microbial contamination | The firm distributes dietary supplements which contain Mitragyna speciosa (kratom) a dietary ingredient with inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Also, based on FDA sample positive sample results, the red an F-1984-2018 |
| 2018-08-22 | Hard Eight Nutrition LLC | Class II | Labeling, manufacturing, potency or other | FDA inspection found two lots of supplements that did not declare shellfish as an ingredient on the product label; shellfish is properly declared on website. F-1827-2018 |
| 2018-08-15 | Seroyal International, a division of Atrium Innovations | Class II | Contaminants, adulteration or foreign material | Microcystins level found to be above the specification limit of NMT1 ppm as per Raw Material Specification. F-1756-2018 |
| 2018-08-08 | LL'S MAGNETIC CLAY INC | Class I | Undeclared allergen | The recalled dietary supplement has the potential to contain undeclared allergens, including almonds, shellfish, milk, eggs, and peanuts. F-1675-2018 |
| 2018-08-01 | Sisel International Llc | Class III | Unapproved drug claims or misbranding | Firm is recalling SiselRipt due to the presence of an unapproved artificial sweetener, Cyclamates. F-1662-2018 |
| 2018-07-04 | Nutreglo Products, LLC. | Class II | Unapproved drug claims or misbranding | The product Blood & Internal Cleanser is a dietary supplement with drug claims and iron content at 67 & 69% of declared, per laboratory results. The product Belly Fat Reducer + Energy Booster and Stamina declares incorrect amount of Vitamin B6. The product label declares 50mg and only contains 0.1 mg as per laboratory F-1591-2018 |
| 2018-07-04 | Nutreglo Products, LLC. | Class III | Unapproved drug claims or misbranding | The product Blood & Internal Cleanser is a dietary supplement with drug claims and iron content at 67 & 69% of declared, per laboratory results. The product Belly Fat Reducer + Energy Booster and Stamina declares incorrect amount of Vitamin B6. The product label declares 50mg and only contains 0.1 mg as per laboratory F-1590-2018 |
| 2018-05-30 | Nature's Only Choice | Class II | Unapproved drug claims or misbranding | The Vitamin B17 containing product is considered to be a prescription drug, new drug, and unapproved new drug. F-1480-2018 |
| 2018-05-16 | Grato Holdings, Inc. | Class II | Unapproved drug claims or misbranding | Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration. F-1402-2018 |
| 2018-05-16 | Grato Holdings, Inc. | Class II | Unapproved drug claims or misbranding | Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration. F-1400-2018 |
| 2018-05-16 | Grato Holdings, Inc. | Class II | Unapproved drug claims or misbranding | Multiple products marketed as dietary supplements are unapproved new drugs based on disease claims or routes of administration. F-1403-2018 |
| 2018-05-02 | AdvoCare International, LP | Class II | Undeclared allergen | Undeclared milk in a dietary supplement F-1125-2018 |
| 2018-05-02 | NGB, Corp | Class I | Microbial contamination | NGB Corp is recalling Nxtgen Botanicals due to potential Salmonella contamination. F-1134-2018 |
| 2018-05-02 | AdvoCare International, LP | Class II | Undeclared allergen | Undeclared milk in a dietary supplement F-1124-2018 |
| 2018-04-25 | Divinity Product Distribution LLC | Class II | Labeling, manufacturing, potency or other | The firm's dietary supplement products contain kratom (Mitragyna speciosa), a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury; F-1020-2018 |
| 2018-04-18 | Bestco, Inc. | Class III | Labeling, manufacturing, potency or other | A packaging revision and lack of revision to the corresponding packaging batch record caused the labeling for the firm's Signature Care brand Calcium Chews dietary supplement to declare a higher level of Vitamin D than the product actually contained. The bag declares 25 mcg (1000 IU) of Vitamin D. The product actually F-1013-2018 |
| 2018-04-04 | Jimmy Weber | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction. D-0625-2018 |
| 2018-03-28 | Avalon Packaging | Class I | Microbial contamination | Avalon Packaging is recalling NXTGEN Kratom because of the potential for Salmonella contamination. F-0996-2018 |
| 2018-03-14 | Vitalab Co Inc | Class II | Undeclared allergen | The firm's vitamin C dietary supplement contains lactose, a milk-derived ingredient, but fails to declare the major food allergen "milk" on the label. F-0883-2018 |
| 2018-02-21 | Kingston Pharma LLC | Class II | Labeling, manufacturing, potency or other | Gas developing in sealed bottle. F-0796-2018 |
| 2018-02-14 | Bulletproof 360 Inc | Class I | Undeclared allergen | Bulletproof Collagen Protein is recalled due to undeclared milk. The actual product inside the package is whey (milk) protein but mis-labeled as collagen protein. F-0774-2018 |
| 2018-02-07 | Jarrow Formulas Inc | Class II | Labeling, manufacturing, potency or other | A higher than normal micro result was found at the six month time point for one lot of Liquid L-Carnitine. F-0682-2018 |
| 2017-12-06 | Pure Encapsulations, Inc. | Class III | Other undeclared ingredient or label mismatch | Product contains undeclared sulfites. F-0396-2018 |
| 2017-12-06 | Pure Encapsulations, Inc. | Class III | Other undeclared ingredient or label mismatch | Product contains undeclared sulfites. F-0397-2018 |
| 2017-12-06 | Reese Pharmaceutical Company | Class II | Labeling, manufacturing, potency or other | The label does not list "Sodium" in the ingredient statement. F-0408-2018 |
| 2017-12-06 | Reese Pharmaceutical Company | Class II | Labeling, manufacturing, potency or other | The label does not list "Sodium" in the ingredient statement. F-0409-2018 |
| 2017-11-08 | Kiriko, LLC. | Class II | Undeclared drug ingredient | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall. D-0058-2018 |
| 2017-10-11 | Pro Bioteks Laboratories | Class II | Undeclared allergen | Bio-35 has undeclared soy lecithin. F-0009-2018 |
| 2017-08-30 | Grandma's Herbs | Class III | Undeclared allergen | Grandmas Herbs Cholesterol has undeclared soy lecithin. F-3409-2017 |
| 2017-08-23 | NatureAll-STF Holding, LLC | Class I | Undeclared allergen | Undeclared allergens: milk (Colostrum, Dried Yogurt, Whey). F-3367-2017 |
| 2017-08-23 | NatureAll-STF Holding, LLC | Class II | Undeclared allergen | Undeclared allergens: soy (lecithin) F-3374-2017 |
| 2017-08-23 | NatureAll-STF Holding, LLC | Class II | Undeclared allergen | Undeclared allergens: soy (lecithin) F-3370-2017 |
| 2017-08-23 | NatureAll-STF Holding, LLC | Class II | Undeclared allergen | Undeclared allergens: soy (lecithin) F-3372-2017 |
| 2017-08-23 | NatureAll-STF Holding, LLC | Class I | Undeclared allergen | Undeclared allergens: milk (Colostrum) F-3369-2017 |
| 2017-08-23 | NatureAll-STF Holding, LLC | Class II | Undeclared allergen | Undeclared allergens: soy (lecithin) F-3371-2017 |
| 2017-08-23 | NatureAll-STF Holding, LLC | Class I | Undeclared allergen | Undeclared allergens: milk (Whey) F-3368-2017 |
| 2017-08-23 | NatureAll-STF Holding, LLC | Class II | Undeclared allergen | Undeclared allergens: soy (lecithin) F-3373-2017 |
| 2017-08-23 | Genetic Edge Compounds LLC | Class I | Undeclared drug ingredient | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances. D-1092-2017 |
| 2017-08-16 | Duy Drugs Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Failure to meet with 21 CFR Part 111, CGMPs, assuring identity, purity, and composition of dietary supplements. F-3356-2017 |
| 2017-08-16 | Duy Drugs Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Failure to meet with 21 CFR Part 111, CGMPs, assuring identity, purity, and composition of dietary supplements. F-3355-2017 |
| 2017-08-09 | Professional Complementary Health Formulas, LLC | Class II | Other undeclared ingredient or label mismatch | Sublinqual B12 tablets are recalled because the ingredients statement declared lactose but label does not declare milk. F-3348-2017 |
| 2017-07-19 | Organic Herbal Supply | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin D-0967-2017 |
| 2017-07-19 | Organic Herbal Supply | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin D-0964-2017 |
| 2017-07-19 | Organic Herbal Supply | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin D-0969-2017 |
| 2017-07-19 | Organic Herbal Supply | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin D-0962-2017 |
| 2017-07-19 | Organic Herbal Supply | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin D-0965-2017 |
| 2017-07-19 | Organic Herbal Supply | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin D-0971-2017 |
| 2017-07-19 | Organic Herbal Supply | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin D-0961-2017 |
| 2017-07-19 | Organic Herbal Supply | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin D-0963-2017 |
| 2017-07-19 | Organic Herbal Supply | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin D-0966-2017 |
| 2017-07-19 | Organic Herbal Supply | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin D-0970-2017 |
| 2017-07-19 | Organic Herbal Supply | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin D-0968-2017 |
| 2017-07-12 | Nutri-Dyn Midwest, Inc. | Class II | Labeling, manufacturing, potency or other | During production of St. John's Wort, Lot 160876, a number of bottles were mistakenly labeled as Calcium D-Glucarate Plus F-2423-2017 |
| 2017-06-28 | Genetic Edge Compounds LLC | Class II | Undeclared drug ingredient | Product contains DMAA and Methylsynephrine. F-2384-2017 |
| 2017-06-07 | MusclMasster, LLC | Class I | Undeclared drug ingredient | MusclMasster, LLC is recalling all bottles of Al-Er-G Capsules because they contain the presence of Ephedra Herb, an FDA banned ingredient. F-2291-2017 |
| 2017-05-31 | RB Manufacturing LLC | Class III | Labeling, manufacturing, potency or other | RB Manufacturing is recalling Move Free Advance Tablets due to incorrect packaging. F-2250-2017 |
| 2017-05-10 | Threshold Enterprises Ltd | Class II | Labeling, manufacturing, potency or other | Testing of Vitamin D-3 as a result of a consumer complaint found specific lots to have lower concentrations than product specifications of ingredient labeling. F-2178-2017 |
| 2017-05-03 | Armada Nutrition | Class II | Microbial contamination | A raw material initially failed testing Staphylococcus aureus. A retest was conducted with passing results but an out of specification investigation was not properly conducted leaving concern that the finished product could contain the bacterium. F-2150-2017 |
| 2017-04-12 | Organic Herbal Supply | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which is an active pharmaceutical ingredient in a FDA approved drug used to treat erectile dysfunction (ED). D-0646-2017 |
| 2017-04-05 | Butala Emporium, Inc. | Class I | Contaminants, adulteration or foreign material | The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits. F-1811-2017 |
| 2017-04-05 | Butala Emporium, Inc. | Class I | Contaminants, adulteration or foreign material | The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits. F-1813-2017 |
| 2017-04-05 | Butala Emporium, Inc. | Class I | Contaminants, adulteration or foreign material | The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits. F-1818-2017 |
| 2017-04-05 | Butala Emporium, Inc. | Class I | Contaminants, adulteration or foreign material | The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits . F-1809-2017 |
| 2017-04-05 | Butala Emporium, Inc. | Class I | Contaminants, adulteration or foreign material | The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits. F-1815-2017 |
| 2017-04-05 | Butala Emporium, Inc. | Class I | Contaminants, adulteration or foreign material | The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits . F-1810-2017 |
| 2017-04-05 | Butala Emporium, Inc. | Class I | Contaminants, adulteration or foreign material | The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits. F-1817-2017 |
| 2017-04-05 | Butala Emporium, Inc. | Class I | Contaminants, adulteration or foreign material | The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits. F-1812-2017 |
| 2017-04-05 | Butala Emporium, Inc. | Class I | Contaminants, adulteration or foreign material | The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits. F-1816-2017 |
| 2017-04-05 | Butala Emporium, Inc. | Class I | Contaminants, adulteration or foreign material | The dietary supplements were found to contain lead, mercury and/or arsenic at levels exceeding permissible limits. F-1814-2017 |
| 2017-03-22 | Kingsway Trading Inc | Class I | Undeclared drug ingredient | Presence of Ephedrae Herba (ma huang), a FDA Banned Ephedra Alkaloid F-1577-2017 |
| 2017-02-22 | NOW Foods | Class III | Labeling, manufacturing, potency or other | Product's supplement fact panel incorrectly states that the product contains 75 mg (milligrams) of Molybdenum, when it actually contains 75 mcg (micrograms). F-1484-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1033-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1045-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1022-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1015-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1039-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1078-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1027-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1080-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1024-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1012-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1017-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1064-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1026-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1013-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1042-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1036-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1004-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1065-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1031-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1043-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1020-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1055-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1019-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1049-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1044-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1038-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1016-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1057-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1053-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1073-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1056-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1032-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1018-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1011-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1014-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1041-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1069-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1028-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1046-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1062-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1066-2017 |
| 2017-01-04 | Bio-Botanica, Inc. | Class II | Labeling, manufacturing, potency or other | The lots exceed the label claim for Vitamin D3 of 2000 IU per drop. F-0906-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1052-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1007-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1063-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1023-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1070-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1074-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1060-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1075-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1034-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1037-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1050-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1047-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1058-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1076-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1021-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1005-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1059-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1040-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1071-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1051-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1072-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1025-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1081-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1061-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1010-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1079-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1030-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1035-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1029-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1006-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1067-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1077-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1068-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1054-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1048-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1008-2017 |
| 2017-01-04 | Sunset Natural Products Inc. | Class II | Manufacturing practice (cGMP) or consent decree | Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operati F-1009-2017 |
| 2017-01-04 | VIRTUS PHARMACEUTICALS OPCO II L | Class III | Undeclared drug ingredient | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. D-0240-2017 |
| 2017-01-04 | VIRTUS PHARMACEUTICALS OPCO II L | Class III | Undeclared drug ingredient | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. D-0239-2017 |
| 2017-01-04 | VIRTUS PHARMACEUTICALS OPCO II L | Class III | Undeclared drug ingredient | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. D-0238-2017 |
| 2016-12-28 | Chaos and Pain | Class II | Other undeclared ingredient or label mismatch | Product was analyzed and found to contain 1,3- dimethylbutylamine which was not declared on the label and is a prohibited substance. F-0766-2017 |
| 2016-12-14 | Nutra Manufacturing | Class I | Undeclared allergen | Undeclared Allergen: Milk. F-0626-2017 |
| 2016-11-16 | Professional Botanicals | Class I | Undeclared allergen | Professional Botanicals announces a voluntary field action for MealPlex and Pearl due to undeclared milk allergen. F-0351-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0276-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0267-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0257-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0273-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0272-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0262-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0260-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0269-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0266-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0275-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0255-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0261-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0268-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0271-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0264-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0256-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0254-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0270-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0265-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0259-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0258-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0274-2017 |
| 2016-11-02 | Pharmatech LLC | Class II | Microbial contamination | Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia. F-0263-2017 |
| 2016-10-26 | Triceutical Inc./Zhang | Class III | Manufacturing practice (cGMP) or consent decree | Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices. F-0094-2017 |
| 2016-10-26 | Triceutical Inc./Zhang | Class III | Manufacturing practice (cGMP) or consent decree | Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices. F-0090-2017 |
| 2016-10-26 | Awareness Corporation | Class I | Microbial contamination | Boost Tea is being recalled for potential Salmonella contamination. F-0118-2017 |
| 2016-10-26 | Triceutical Inc./Zhang | Class III | Manufacturing practice (cGMP) or consent decree | Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices. F-0095-2017 |
| 2016-10-26 | Triceutical Inc./Zhang | Class III | Manufacturing practice (cGMP) or consent decree | Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices. F-0091-2017 |
| 2016-10-26 | Triceutical Inc./Zhang | Class III | Manufacturing practice (cGMP) or consent decree | Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices. F-0096-2017 |
| 2016-10-26 | Triceutical Inc./Zhang | Class III | Manufacturing practice (cGMP) or consent decree | Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices. F-0088-2017 |
| 2016-10-26 | Triceutical Inc./Zhang | Class III | Manufacturing practice (cGMP) or consent decree | Triceutical Inc. has recalled all dietary supplements due to lack of good manufacturing practices. F-0089-2017 |
| 2016-10-19 | Complete Packaging & Manufacturing, LLC | Class I | Undeclared allergen | Nature's Power Solutions Acidophilus Blend due to undeclared milk allergen. F-0049-2017 |
| 2016-10-19 | Bee Xtreme | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein D-0020-2017 |
| 2016-10-19 | Bee Xtreme | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein D-0021-2017 |
| 2016-10-19 | Bee Xtreme | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein D-0019-2017 |
| 2016-09-21 | Ultimate Nutrition, Inc. | Class I | Undeclared allergen | Product contains undeclared milk. F-1770-2016 |
| 2016-09-21 | Ultimate Nutrition, Inc. | Class I | Undeclared allergen | Product contains undeclared milk. F-1769-2016 |
| 2016-09-21 | Ultimate Nutrition, Inc. | Class I | Undeclared allergen | Product contains undeclared milk. F-1768-2016 |
| 2016-07-13 | Zarbee's Naturals Inc. | Class III | Labeling, manufacturing, potency or other | Some units of each lot may contain contaminants (elevated aerobic plate count) and do not meet acceptable visual appearance standards for the product. F-1617-2016 |
| 2016-07-13 | Zarbee's Naturals Inc. | Class III | Labeling, manufacturing, potency or other | Some units of each lot may contain contaminants (elevated aerobic plate count) and do not meet acceptable visual appearance standards for the product. F-1618-2016 |
| 2016-06-15 | Novacare, LLC | Class I | Labeling, manufacturing, potency or other | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. D-0970-2016 |
| 2016-06-15 | Novacare, LLC | Class I | Labeling, manufacturing, potency or other | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. D-0968-2016 |
| 2016-06-15 | Novacare, LLC | Class I | Labeling, manufacturing, potency or other | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. D-0969-2016 |
| 2016-06-15 | Novacare, LLC | Class I | Labeling, manufacturing, potency or other | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. D-0964-2016 |
| 2016-06-15 | Novacare, LLC | Class I | Labeling, manufacturing, potency or other | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. D-0972-2016 |
| 2016-06-15 | Novacare, LLC | Class I | Labeling, manufacturing, potency or other | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. D-0971-2016 |
| 2016-06-15 | Novacare, LLC | Class I | Labeling, manufacturing, potency or other | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. D-0966-2016 |
| 2016-06-15 | Novacare, LLC | Class I | Labeling, manufacturing, potency or other | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. D-0965-2016 |
| 2016-06-08 | Pronutri, LLC | Class I | Undeclared allergen | Undeclared whey protein which contains the allergens milk and soy lecithin. F-1404-2016 |
| 2016-06-08 | Liquid Assets Inc | Class I | Undeclared allergen | Dietary Supplements contain undeclared milk and soy. F-1406-2016 |
| 2016-06-01 | Centro Naturista | Class I | Undeclared drug ingredient | Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein. D-0878-2016 |
| 2016-06-01 | Centro Naturista | Class I | Undeclared drug ingredient | Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein. D-0877-2016 |
| 2016-05-25 | FoodState, Inc | Class II | Labeling, manufacturing, potency or other | Multi Vitamin label fails to have required warning statement for iron and child resistant cap F-1362-2016 |
| 2016-05-25 | Empirical Laboratories, Incorporated | Class II | Microbial contamination | Empirical Labs is recalling Liposomal Magnesium because of the potential for mold contamination. F-1366-2016 |
| 2016-04-27 | Centro Naturista | Class II | Labeling, manufacturing, potency or other | Multiple dietary supplement regulation violations. F-1095-2016 |
| 2016-04-13 | Immuno - Dynamics, Inc | Class III | Labeling, manufacturing, potency or other | The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk. F-1013-2016 |
| 2016-04-13 | Immuno - Dynamics, Inc | Class III | Labeling, manufacturing, potency or other | The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk. F-1014-2016 |
| 2016-04-13 | Immuno - Dynamics, Inc | Class II | Labeling, manufacturing, potency or other | The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk. F-1016-2016 |
| 2016-04-13 | Immuno - Dynamics, Inc | Class III | Labeling, manufacturing, potency or other | The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk. F-1015-2016 |
| 2016-04-13 | Immuno - Dynamics, Inc | Class III | Labeling, manufacturing, potency or other | The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk. F-1017-2016 |
| 2016-04-13 | Virtus Pharmaceuticals, Llc | Class III | Labeling, manufacturing, potency or other | Defective Delivery System: Product may contain leaking capsules. D-0801-2016 |
| 2016-04-06 | ProSupps USA LLC | Class II | Other undeclared ingredient or label mismatch | Product could be potentially mislabeled and contain non-dietary ingredient Picamilon. F-0998-2016 |
| 2016-04-06 | ProSupps USA LLC | Class II | Other undeclared ingredient or label mismatch | Product could be potentially mislabeled and contain non-dietary ingredient Picamilon. F-1000-2016 |
| 2016-04-06 | ProSupps USA LLC | Class II | Other undeclared ingredient or label mismatch | Product could be potentially mislabeled and contain non-dietary ingredient Picamilon. F-0999-2016 |
| 2016-04-06 | ProSupps USA LLC | Class II | Other undeclared ingredient or label mismatch | Product could be potentially mislabeled and contain non-dietary ingredient Picamilon. F-1001-2016 |
| 2016-04-06 | ProSupps USA LLC | Class II | Other undeclared ingredient or label mismatch | Product could be potentially mislabeled and contain non-dietary ingredient Picamilon. F-0997-2016 |
| 2016-03-23 | Virtus Pharmaceuticals, Llc | Class III | Labeling, manufacturing, potency or other | Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate). D-0775-2016 |
| 2016-02-24 | Life and More LLC | Class I | Undeclared drug ingredient | Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling. D-0664-2016 |
| 2015-12-09 | VRVK Nutraceuticals, LLC | Class I | Undeclared allergen | The dietary supplement contains undeclared milk and crustacean shellfish based on FDA's inspection. F-0332-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0051-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0058-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0066-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0055-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0034-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0046-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0060-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0057-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0052-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0039-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0035-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0054-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0050-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0044-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0049-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0033-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0040-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0045-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0059-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0056-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0053-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and/or colostrum are not labeled as containing milk F-0032-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0042-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0029-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0037-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0047-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0064-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0063-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0030-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0041-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0038-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0036-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0031-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0065-2016 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0048-2916 |
| 2015-10-28 | Nutrition Resource Services, Inc. | Class II | Undeclared allergen | Protein powders and nutritional supplement products made of whey concentrate, whey isolate, casein, and colostrum are not labeled as containing milk F-0043-2016 |
| 2015-08-19 | Mason Vitamins, Inc. | Class III | Other undeclared ingredient or label mismatch | Product is mislabeled. Some of the Co Q 10 30 mg bottles were labeled with the incorrect label, Co Q 10 50 mg. F-2951-2015 |
| 2015-08-12 | MedOp Health, Inc. | Class III | Potency, dissolution or quality defect | Maxivision MaxiFlex (Registered) Multinutrient Formula, 120 Vegetable Capsules is being recalled because a material review was conducted in April 2015. It revealed some of the Chondroitin Sulfate (Lot 093011 1031) raw material used in the manufacture of Maxiflex Multinutrient Formula Lot 32171215 was Out of Specificati F-2942-2015 |
| 2015-06-03 | Uber Vita LLC | Class II | Labeling, manufacturing, potency or other | It has come to the attention of Ubervita LLC that a packaging error has occurred with a product exclusively made for Walmart Stores. This issue applies to less than 30 units of its W700 Lose Weight product. While the vitamin bottles are labeled accurately, less than 30-bottles of UBERTEST TESTOSTERONE EXTREME BOOST FOR F-2323-2015 |
| 2015-05-13 | Ultra ZX Supplements | Class I | Undeclared drug ingredient | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein D-0991-2015 |
| 2015-05-06 | A2Z Industries, LLC | Class II | Undeclared drug ingredient | Product contains anabolic steroid. F-2041-2015 |
| 2015-04-15 | Nutri-Dyn Midwest, Inc. | Class III | Other undeclared ingredient or label mismatch | Nutri-Dyn has initiated a recall due to mislabeling. During production of CoQ-10, Lot #140186, one or more bottles were mistakenly labeled as 5-HTP Extra Strength. F-1922-2015 |
| 2015-04-08 | ProSupps USA LLC | Class II | Labeling, manufacturing, potency or other | The product contains more yohimbine hcl than declared on the label F-1783-2015 |
| 2015-02-04 | The Harvard Drug Group, LLC | Class III | Labeling, manufacturing, potency or other | The firm received a complaint that the blister packets were missing labeling information on 12/16/2014, the firm investigated the labeling complaint and found that six 2 x 5 blister cards inside a carton was missing some or all of the product information on the back of the blister card. F-0925-2015 |
| 2014-12-31 | Chaotic Labz | Class II | Other undeclared ingredient or label mismatch | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug. D-0314-2015 |
| 2014-11-26 | Formulations For Life | Class II | Unapproved drug claims or misbranding | Formulations For Life has recalled 3 varieties of Dietary Supplements due to lack of Good Manufacturing Practices and misbranding. F-0526-2015 |
| 2014-11-26 | Formulations For Life | Class II | Unapproved drug claims or misbranding | Formulations For Life has recalled 3 varieties of Dietary Supplements due to lack of Good Manufacturing Practices and misbranding. F-0527-2015 |
| 2014-11-26 | Formulations For Life | Class II | Unapproved drug claims or misbranding | Formulations For Life has recalled 3 varieties of Dietary Supplements due to lack of Good Manufacturing Practices and misbranding. F-0525-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergen milk F-0480-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergen: milk F-0489-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergen: milk F-0493-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergen milk F-0476-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergen: milk F-0491-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergens: milk, shellfish F-0479-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergens: milk and coconut F-0485-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergens: milk F-0488-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergen milk F-0475-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergen: milk F-0474-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergen milk F-0487-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergen: milk F-0490-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergens: milk, shellfish F-0478-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergens: milk F-0484-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergen: milk F-0492-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergens: milk, shellfish F-0482-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergen: milk F-0494-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergen milk F-0486-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergens: milk F-0483-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergens milk F-0481-2015 |
| 2014-11-19 | Maine Natural Health, Inc. | Class I | Undeclared allergen | Protein supplement fails to declare allergens: milk, shellfish F-0477-2015 |
| 2014-11-12 | AMS Health Sciences | Class I | Microbial contamination | The product is being recalled due to the potential presence of Salmonella. F-0462-2015 |
| 2014-10-01 | Arise & Shine Herbal Products, Inc. | Class II | Labeling, manufacturing, potency or other | Arise & Shine Herbal Products, Inc. is voluntarily recalling Hydrated Bentonite 32 oz liquid pouch due to mis-labeling. The product is labeled as containing 0% Daily Value of iron and actually contains 106% Daily Value of iron. F-2514-2014 |
| 2014-09-24 | Vibrant Health | Class I | Microbial contamination | A raw material used in the manufacture of the dietary supplements was found to contain Salmonella bacteria. F-2434-2014 |
| 2014-09-24 | Nature's Universe | Class I | Undeclared drug ingredient | Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. D-1594-2014 |
| 2014-09-17 | ChiroNutraceutical LLC | Class III | Unapproved drug claims or misbranding | Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG. D-1569-2014 |
| 2014-09-10 | Ortho Molecular Products Inc | Class I | Undeclared allergen | Ortho Molecular Products is recalling all lots of LifeCore Chocolate and LifeCore Complete Chocolate because the flavoring may contain undeclared milk. F-2414-2014 |
| 2014-09-10 | Ortho Molecular Products Inc | Class I | Undeclared allergen | Ortho Molecular Products is recalling all lots of LifeCore Chocolate and LifeCore Complete Chocolate because the flavoring may contain undeclared milk. F-2413-2014 |
| 2014-09-03 | Regeneca, Inc | Class II | Undeclared drug ingredient | RegeneSlim was found to contain DMAA by FDA analysis. F-2403-2014 |
| 2014-08-20 | Sung Soo Kim | Class I | Other undeclared ingredient or label mismatch | Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone. D-1535-2014 |
| 2014-07-30 | Country Life | Class II | Labeling, manufacturing, potency or other | The affected lots do not meet quality standards due to insoluble particulates. F-2196-2014 |
| 2014-07-09 | Physique Enhancing Science | Class II | Unapproved drug claims or misbranding | Products contain "Aegeline" an unapproved New Dietary Ingredient. F-2054-2014 |
| 2014-07-09 | Physique Enhancing Science | Class II | Unapproved drug claims or misbranding | Products contain "Aegeline" an unapproved New Dietary Ingredient. F-2055-2014 |
| 2014-06-25 | Nutrition Center, Inc. dba Nutri-West | Class II | Contaminants, adulteration or foreign material | Nutrition Center voluntarily recalled Total Enzymes and Total Probiotics after notification from supplier that raw materials may potentially contain Chloramphenicol. F-2031-2014 |
| 2014-06-25 | Nutrition Center, Inc. dba Nutri-West | Class II | Contaminants, adulteration or foreign material | Nutrition Center voluntarily recalled Total Enzymes and Total Probiotics after notification from supplier that raw materials may potentially contain Chloramphenicol. F-2032-2014 |
| 2014-06-18 | Pure Edge Nutrition | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein D-1368-2014 |
| 2014-06-18 | Pure Edge Nutrition | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein D-1370-2014 |
| 2014-06-18 | Pure Edge Nutrition | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein D-1367-2014 |
| 2014-06-18 | Vitality Research Labs LLC | Class I | Undeclared drug ingredient | Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules D-1364-2014 |
| 2014-06-18 | Pure Edge Nutrition | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein D-1366-2014 |
| 2014-06-18 | Pure Edge Nutrition | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein D-1365-2014 |
| 2014-06-18 | Pure Edge Nutrition | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein D-1369-2014 |
| 2014-05-28 | Independent Nutrition Center, Inc. | Class II | Unapproved drug claims or misbranding | Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug. D-1349-2014 |
| 2014-05-28 | HUMAN SCIENCE FOUNDATION | Class I | Labeling, manufacturing, potency or other | Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin D-1327-2014 |
| 2014-05-28 | Schindele Enterprises dba Midwest Wholesale | Class I | Undeclared drug ingredient | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. D-1335-2014 |
| 2014-05-28 | Tendex | Class I | Undeclared drug ingredient | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs. D-1345-2014 |
| 2014-05-28 | Tendex | Class I | Undeclared drug ingredient | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs. D-1346-2014 |
| 2014-05-28 | Herbal Give Care Llc | Class I | Undeclared drug ingredient | Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs. D-1332-2014 |
| 2014-05-07 | Deseo Rebajar | Class I | Undeclared drug ingredient | Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement. D-1277-2014 |
| 2014-04-23 | Magno Humphries Laboratories, Inc | Class II | Labeling, manufacturing, potency or other | Magno Humphries Laboratories is recalling Vitamin E softgels because the principle display panel states the product contains 1000 IU of Vitamin E however the Supplement Facts label indicated 200 IU of Vitamin E. The supplement actually contains 1000 IU of Vitamin E. F-1821-2014 |
| 2014-04-23 | B @ B Trade Inc. | Class I | Undeclared drug ingredient | Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine D-1231-2014 |
| 2014-04-23 | B @ B Trade Inc. | Class I | Undeclared drug ingredient | Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine D-1233-2014 |
| 2014-04-23 | Haute Health, LLC | Class I | Unapproved drug claims or misbranding | Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug. D-1235-2014 |
| 2014-04-23 | B @ B Trade Inc. | Class I | Undeclared drug ingredient | Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine D-1232-2014 |
| 2014-04-16 | Nature's Value Inc. | Class II | Labeling, manufacturing, potency or other | The product was produced using bulk L-Citrulline lot # 121109 which was subsequently recalled by the supplier since the lot was found to contain a compound other than L-Citrulline. F-1762-2014 |
| 2014-04-16 | Smiley National Inc | Class II | Unapproved drug claims or misbranding | Smiley National is voluntarily recalling all lots of Bali Kratom 40, XL Kratom, Maeng da Kratom, and Max Kratom due to the presence of unapproved dietary ingredients. F-1757-2014 |
| 2014-04-16 | Nature's Value Inc. | Class II | Labeling, manufacturing, potency or other | The product was produced using bulk L-Citrulline lot # 121109 which was subsequently recalled by the supplier since the lot was found to contain a compound other than L-Citrulline. F-1761-2014 |
| 2014-04-16 | Smiley National Inc | Class II | Unapproved drug claims or misbranding | Smiley National is voluntarily recalling all lots of Bali Kratom 40, XL Kratom, Maeng da Kratom, and Max Kratom due to the presence of unapproved dietary ingredients. F-1755-2014 |
| 2014-04-16 | American Lifestyle.Com | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and D-1223-2014 |
| 2014-03-19 | CTV Best Group | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA: Product contains an undeclared drug, sibutramine, making it an unapproved new drug. D-1154-2014 |
| 2014-03-12 | Mira Health Products Ltd. | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, making it an unapproved new drug D-1150-2014 |
| 2014-03-12 | Mira Health Products Ltd. | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug D-1151-2014 |
| 2014-03-05 | Nature's Value Inc. | Class II | Contaminants, adulteration or foreign material | The dietary supplement lot contains Chloramphenicol at a level of 9.7 ppb. F-1569-2014 |
| 2014-02-26 | STEMVIDA INTERNATIONAL INC | Class I | Undeclared allergen | Stemvida International Corporation of Ontario California is recalling certain lots of StemAlive 90 Capsules, because it contains undeclared milk. F-1536-2014 |
| 2014-02-12 | Health & Beyond | Class II | Labeling, manufacturing, potency or other | Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic) D-1067-2014 |
| 2014-02-05 | Health Wright Products Inc | Class II | Contaminants, adulteration or foreign material | Dietary supplement products are recalled because they were made from ingredient that was contaminated with Chloramphenicol. F-1461-2014 |
| 2014-02-05 | Health Wright Products Inc | Class II | Contaminants, adulteration or foreign material | Dietary supplement products are recalled because they were made from ingredient that was contaminated with Chloramphenicol. F-1458-2014 |
| 2014-02-05 | Health Wright Products Inc | Class II | Contaminants, adulteration or foreign material | Dietary supplement products are recalled because they were made from ingredient that was contaminated with Chloramphenicol. F-1460-2014 |
| 2014-02-05 | Health Wright Products Inc | Class II | Contaminants, adulteration or foreign material | Dietary supplement products are recalled because they were made from ingredient that was contaminated with Chloramphenicol. F-1459-2014 |
| 2014-02-05 | Health Wright Products Inc | Class II | Contaminants, adulteration or foreign material | Dietary supplement products are recalled because they were made from ingredient that was contaminated with Chloramphenicol. F-1456-2014 |
| 2014-02-05 | IQ Formulations, LLC | Class I | Other undeclared ingredient or label mismatch | Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug D-1050-2014 |
| 2014-01-22 | USPlabs, LLC | Class I | Labeling, manufacturing, potency or other | USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure. F-1372-2014 |
| 2014-01-22 | USPlabs, LLC | Class I | Labeling, manufacturing, potency or other | USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure. F-1370-2014 |
| 2014-01-22 | USPlabs, LLC | Class I | Labeling, manufacturing, potency or other | USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure. F-1376-2014 |
| 2014-01-22 | USPlabs, LLC | Class I | Labeling, manufacturing, potency or other | USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure. F-1375-2014 |
| 2014-01-22 | USPlabs, LLC | Class I | Labeling, manufacturing, potency or other | USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure. F-1374-2014 |
| 2014-01-22 | USPlabs, LLC | Class I | Labeling, manufacturing, potency or other | USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure. F-1373-2014 |
| 2014-01-22 | USPlabs, LLC | Class I | Labeling, manufacturing, potency or other | USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure. F-1371-2014 |
| 2014-01-15 | Innovative Labs, LLC | Class II | Microbial contamination | Innovative Labs, LLC. has recalled two Dietary Supplements due to the presence of Chloramphenicol, an antimicrobial agent. F-1382-2014 |
| 2014-01-15 | Perrigo of SC | Class II | Contaminants, adulteration or foreign material | Potential presence of Chloramphenicol contamination F-1384-2014 |
| 2014-01-15 | Innovative Labs, LLC | Class II | Microbial contamination | Innovative Labs, LLC. has recalled two Dietary Supplements due to the presence of Chloramphenicol, an antimicrobial agent. F-1381-2014 |
| 2014-01-01 | Vega / Sequel Naturals | Class II | Contaminants, adulteration or foreign material | Sequel Naturals is recalling nine lots of products due to contamination by trace amount of chloramphenicol. F-1140-2014 |
| 2014-01-01 | Vega / Sequel Naturals | Class II | Contaminants, adulteration or foreign material | Sequel Naturals is recalling nine lots of products due to contamination by trace amount of chloramphenicol. F-1141-2014 |
| 2013-12-25 | Global Health Laboratories, LLC | Class II | Contaminants, adulteration or foreign material | The finished dietary supplement product was manufactured with ingredients subsequently found to be contaminated with chloramphenicol, an antibiotic, at levels above 0.3 ppb. The supplier, Specialty Enzymes & Biotechnologies, recalled the raw materials and notified the recipients. Subsequent private laboratory testing o F-1105-2014 |
| 2013-12-25 | National Enzyme Co | Class II | Contaminants, adulteration or foreign material | Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol F-0746-2014 |
| 2013-12-25 | Global Health Laboratories, LLC | Class II | Contaminants, adulteration or foreign material | The finished dietary supplement product was manufactured with ingredients found to be contaminated with chloramphenicol, an antibiotic, above levels of 0.3 ppb. F-1112-2014 |
| 2013-12-25 | National Enzyme Co | Class II | Contaminants, adulteration or foreign material | Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol F-0790-2014 |
| 2013-12-25 | National Enzyme Co | Class II | Contaminants, adulteration or foreign material | Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol F-0776-2014 |
| 2013-12-25 | National Enzyme Co | Class II | Contaminants, adulteration or foreign material | Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol F-0750-2014 |
| 2013-12-25 | National Enzyme Co | Class II | Contaminants, adulteration or foreign material | Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol F-0747-2014 |
| 2013-12-25 | National Enzyme Co | Class II | Contaminants, adulteration or foreign material | Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol F-0773-2014 |
| 2013-12-25 | National Enzyme Co | Class II | Contaminants, adulteration or foreign material | Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol F-0751-2014 |
| 2013-12-25 | National Enzyme Co | Class II | Contaminants, adulteration or foreign material | Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol F-0735-2014 |
| 2013-12-25 | National Enzyme Co | Class II | Contaminants, adulteration or foreign material | Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol F-0752-2014 |
| 2013-12-25 | Fabscout Entertainment, Inc | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil D-377-2014 |
| 2013-12-11 | Allergy Research Group | Class II | Contaminants, adulteration or foreign material | Firm was notified by their contract manufacturer that a voluntary recall had been issued by the raw material supplier because certain cellulase enzymes have been found to be contaminated with Chloramphenicol. F-703-2014 |
| 2013-12-04 | 4Life Research, LLC | Class II | Contaminants, adulteration or foreign material | 4Life Research, LLC is voluntarily recalling various lots of Digestive Enzymes product due to the presence of trace amounts of the antibiotic, chloramphenicol. F-0349-2014 |
| 2013-12-04 | FoodScience Corporation | Class II | Contaminants, adulteration or foreign material | Dietary supplements are recalled because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol. F-0229-2014 |
| 2013-12-04 | FoodScience Corporation | Class II | Contaminants, adulteration or foreign material | Dietary supplements are recalled because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol. F-0230-2014 |
| 2013-12-04 | Nexgen Pharma, Inc. | Class II | Contaminants, adulteration or foreign material | Nexgen Pharma Inc. is recalling one lot of Woman's Once Daily vitamin because it was contaminated with the antibiotic, Chloramphenicol. F-0382-2014 |
| 2013-12-04 | Pacific Nutritionals | Class II | Contaminants, adulteration or foreign material | Dietary supplement product was made from ingredients that are contaminated with Chloramphenicol. F-0345-2014 |
| 2013-12-04 | Ortho Molecular Products Inc | Class II | Contaminants, adulteration or foreign material | Ortho Molecular Products' vegetable enzyme vendor issued a recall of the raw material due to potential chloramphenicol contamination. F-0348-2014 |
| 2013-12-04 | FoodScience Corporation | Class II | Contaminants, adulteration or foreign material | Dietary supplements are recalled because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol. F-0227-2014 |
| 2013-12-04 | FoodScience Corporation | Class II | Contaminants, adulteration or foreign material | Dietary supplements are recalled because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenicol. F-0228-2014 |
| 2013-12-04 | Pacific Nutritionals | Class II | Contaminants, adulteration or foreign material | Dietary supplement products were made from ingredients that are contaminated with Chloramphenicol. F-0346-2014 |
| 2013-11-27 | New Algae Company | Class I | Other undeclared ingredient or label mismatch | Flex dietary supplement product is recalled because the finished label does not declare shark cartilage. F-0216-2014 |
| 2013-11-27 | Pharmavite Corporation | Class II | Potency, dissolution or quality defect | Pharmavite LLC is conducting a voluntary recall of all lots of its Nature Made Full Strength Mini Multivitamins (recently repackaged as "Multi" softgels, (Multi Complete, Multi for Her, Multi for Her 50+, Multi for Him, Multi Complete club size). because recent quality tests indicate that the Vitamins B1 and B12 are lo F-0186-2014 |
| 2013-11-27 | Diamond Nutriceutical, Inc. | Class II | Labeling, manufacturing, potency or other | The firm initiated this recall in response to FDA sample findings that major ingredients are omitted partially or entirely. The product did not contain the amounts as labeled for Vitamin A and Vitamin C. F-0219-2014 |
| 2013-11-27 | Pharmavite Corporation | Class II | Potency, dissolution or quality defect | Pharmavite LLC is conducting a voluntary recall of all lots of its Nature Made Full Strength Mini Multivitamins (recently repackaged as "Multi" softgels, (Multi Complete, Multi for Her, Multi for Her 50+, Multi for Him, Multi Complete club size). because recent quality tests indicate that the Vitamins B1 and B12 are lo F-0185-2014 |
| 2013-11-27 | ProThera, Inc. | Class II | Contaminants, adulteration or foreign material | Firm was notified by supplier of the enzyme Xylanase that it was contaminated with chloramphenicol. F-0179-2014 |
| 2013-11-27 | ProThera, Inc. | Class II | Contaminants, adulteration or foreign material | Firm was notified by supplier of the enzyme Xylanase that it was contaminated with chloramphenicol. F-0180-2014 |
| 2013-11-27 | New Algae Company | Class I | Other undeclared ingredient or label mismatch | EDGE dietary supplement product is recalled because the finished label does not declare shark cartilage. F-0215-2014 |
| 2013-11-27 | Swanson Health Products, Inc | Class III | Other undeclared ingredient or label mismatch | Swanson Health Products is recalling two lots of Swanson Premium Full Spectrum Black Cumin Seed (Nigella sativa) Dietary Supplement Capsules. The product was found to be mislabel. Bottles of Black Cumin Seed from these two lots numbers (199399 & 201359) have been found to contain White Cumin Seed (Cuminum cyminum). F-0220-2014 |
| 2013-11-27 | Pharmavite Corporation | Class II | Potency, dissolution or quality defect | Pharmavite LLC is conducting a voluntary recall of all lots of its Nature Made Full Strength Mini Multivitamins (recently repackaged as "Multi" softgels, (Multi Complete, Multi for Her, Multi for Her 50+, Multi for Him, Multi Complete club size). because recent quality tests indicate that the Vitamins B1 and B12 are lo F-0187-2014 |
| 2013-11-27 | Pharmavite Corporation | Class II | Potency, dissolution or quality defect | Pharmavite LLC is conducting a voluntary recall of all lots of its Nature Made Full Strength Mini Multivitamins (recently repackaged as "Multi" softgels, (Multi Complete, Multi for Her, Multi for Her 50+, Multi for Him, Multi Complete club size). because recent quality tests indicate that the Vitamins B1 and B12 are lo F-0184-2014 |
| 2013-11-27 | Affirm XL, Inc. | Class I | Undeclared drug ingredient | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug. D-015-2014 |
| 2013-11-20 | Empirical Laboratories, Incorporated | Class II | Contaminants, adulteration or foreign material | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. F-0145-2014 |
| 2013-11-20 | Empirical Laboratories, Incorporated | Class II | Contaminants, adulteration or foreign material | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. F-0149-2014 |
| 2013-11-20 | Empirical Laboratories, Incorporated | Class II | Contaminants, adulteration or foreign material | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. F-0150-2014 |
| 2013-11-20 | Empirical Laboratories, Incorporated | Class II | Contaminants, adulteration or foreign material | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. F-0148-2014 |
| 2013-11-20 | Grato Inc. | Class II | Contaminants, adulteration or foreign material | The products may contain chloramphenicol. F-0164-2014 |
| 2013-11-20 | Bairn Biologics | Class II | Contaminants, adulteration or foreign material | Firm was notified by supplier of xylanase enzymes that they were contaminated with Chloramphenicol. F-0163-2014 |
| 2013-11-20 | Empirical Laboratories, Incorporated | Class II | Contaminants, adulteration or foreign material | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. F-0157-2014 |
| 2013-11-20 | Empirical Laboratories, Incorporated | Class II | Contaminants, adulteration or foreign material | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. F-0153-2014 |
| 2013-11-20 | Empirical Laboratories, Incorporated | Class II | Contaminants, adulteration or foreign material | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. F-0156-2014 |
| 2013-11-20 | Empirical Laboratories, Incorporated | Class II | Contaminants, adulteration or foreign material | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. F-0155-2014 |
| 2013-11-20 | Cgnp Manufacturing | Class II | Contaminants, adulteration or foreign material | CGNP initiated this recall because the raw material Exclezyme received from Specialty Enzymes used by CGNP in the formulation of Beachbody Optimize Enzymes Capsules CG has been found to contain chloramphenicol. F-0166-2014 |
| 2013-11-20 | Apex Energetics | Class II | Contaminants, adulteration or foreign material | Apex Energetics is recalling GlutenFlam, SuperDigestZyme, LGS-Zyme, and RepairVite because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenic F-0142-2014 |
| 2013-11-20 | Apex Energetics | Class II | Contaminants, adulteration or foreign material | Apex Energetics is recalling GlutenFlam, SuperDigestZyme, LGS-Zyme, and RepairVite because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenic F-0144-2014 |
| 2013-11-20 | Empirical Laboratories, Incorporated | Class II | Contaminants, adulteration or foreign material | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. F-0151-2014 |
| 2013-11-20 | Empirical Laboratories, Incorporated | Class II | Contaminants, adulteration or foreign material | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. F-0154-2014 |
| 2013-11-20 | Apex Energetics | Class II | Contaminants, adulteration or foreign material | Apex Energetics is recalling GlutenFlam, SuperDigestZyme, LGS-Zyme, and RepairVite because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenic F-0141-2014 |
| 2013-11-20 | Empirical Laboratories, Incorporated | Class II | Contaminants, adulteration or foreign material | Empirical Labs is recalling certain lots of dietary supplements due to potential for adulteration with chloramphenicol. F-0146-2014 |
| 2013-11-20 | Apex Energetics | Class II | Contaminants, adulteration or foreign material | Apex Energetics is recalling GlutenFlam, SuperDigestZyme, LGS-Zyme, and RepairVite because they may contain trace amounts of the antibiotic chloramphenicol. The dietary supplements on recall contain enzymes that are on recall by Specialty Enzymes Biotechnology, a raw material supplier, because it contains chloramphenic F-0143-2014 |
| 2013-11-13 | Vitalab Co Inc | Class II | Contaminants, adulteration or foreign material | The firm reports a customer found a foreign object in the product. F-0101-2014 |
| 2013-11-13 | Threshold Enterprises Ltd | Class II | Contaminants, adulteration or foreign material | The firm found small piece of metal fragment in one tablet during its inspection process. F-0100-2014 |
| 2013-10-30 | Vinco Inc. | Class II | Microbial contamination | The soy ingredient used to manufacture certain lots of Vinco's Fem-Vite was potentially contaminated with Salmonella. F-0008-2014 |
| 2013-10-30 | NatureMost of New England, Inc. | Class I | Undeclared allergen | Undeclared allergens, milk,almond and soy. F-0078-2014 |
| 2013-10-30 | NatureMost of New England, Inc. | Class I | Undeclared allergen | Undeclared allergens, milk and soy. F-0079-2014 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1938-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class II | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1925-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1934-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1931-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class II | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1926-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1928-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1922-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1940-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1943-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1921-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1930-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1933-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1937-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1924-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1939-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class I | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1923-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1935-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1932-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F1920-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1927-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1942-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1936-2013 |
| 2013-10-02 | Healthmaxx Global Inc. | Class III | Other undeclared ingredient or label mismatch | In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained. F-1941-2013 |
| 2013-09-18 | Reaction Nutrition LLC | Class I | Undeclared allergen | The product contained an undeclared allergen, Colostrum, which is considered a dairy product and therefore requires an allergen statement on the label. F-1879-2013 |
| 2013-09-18 | New Sun Inc | Class II | Microbial contamination | Positive E.coli F-1881-2013 |
| 2013-09-18 | New Sun Inc | Class II | Microbial contamination | Positive E.coli F-1880-2013 |
| 2013-07-17 | Allergy Research Group | Class II | Labeling, manufacturing, potency or other | Allergy Research Group received word from their contract manufacturer, ABCO Laboratories, that two of their products have been manufactured with soy based products from CHS Inc. at it Ashdod, Israel facility. F-1636-2013 |
| 2013-07-10 | Florida Nutri Labs, LLC | Class II | Labeling, manufacturing, potency or other | Customer reported that a product user complained that the caplets were not coated, making them difficult to swallow. F1583-2013 |
| 2013-07-10 | Florida Nutri Labs, LLC | Class II | Labeling, manufacturing, potency or other | Customer reported that a product user complained that the caplets were not coated, making them difficult to swallow. F1582-2013 |
| 2013-07-03 | Enzyme Formulations, Inc. | Class II | Labeling, manufacturing, potency or other | Enzymes Formulations Inc. is recalling Enzyme Solutions Formula 29 8 oz., lot 1225822 because of a labeling error at the manufacturing. This resulted in 10 jars incorrectly containing a Multiple Enzyme Powder. F-1551-2013 |
| 2013-06-26 | Sequel Naturals Ltd | Class I | Labeling, manufacturing, potency or other | Raw material supplier of the chocolate used for the bar coating had milk ingredients added inadvertently. One report of ampholytic reaction. F-1546-2013 |
| 2013-06-26 | Sequel Naturals Ltd | Class I | Labeling, manufacturing, potency or other | Raw material supplier of the chocolate used for the bar coating had milk ingredients added inadvertently. One report of ampholytic reaction. F-1547-2013 |
| 2013-06-26 | Sequel Naturals Ltd | Class I | Labeling, manufacturing, potency or other | Raw material supplier of the chocolate used for the bar coating had milk ingredients added inadvertently. One report of ampholytic reaction. F-1545-2013 |
| 2013-06-19 | Pure Herbs Ltd | Class I | Undeclared allergen | Pure Herbs, Ltd. Protein Extract contains undeclared milk and soy allergens. People who have an allergy or severe sensitivity to milk or soy run the risk of serious or life-threatening allergic reaction if they consume this product. F-1505-2013 |
| 2013-06-19 | Atlantic Pro Nutrients, Inc. dba XYMOGEN | Class I | Undeclared allergen | Undeclared Soy and Milk on the label. F-1523-2013 |
| 2013-05-22 | Juice Bar Solutions | Class III | Labeling, manufacturing, potency or other | It was discovered that label for Add a Scoop Probiotic stated that it was GMO free, however manufacturers paperwork did not support the claim. F-1392-2013 |
| 2013-05-01 | Nexgen Pharma, Inc. | Class III | Potency, dissolution or quality defect | Nexgen Pharma is recalling a certain lot of dietary supplement L-Arginine L-Ornithine Alpha Lipoic Acid Capsules due to subpotency of the Alpha Lipoic Acid ingredient. F-1338-2013 |
| 2013-05-01 | All One, Inc. | Class II | Labeling, manufacturing, potency or other | Product label misprinted to include claim of "No Dairy", even though milk is present in an ingredient (whey protein isolate). "Certified Vegan" is also claimed on the product label. The Supplement Facts panel and side panel discusses the presence of milk in the product. F-1339-2013 |
| 2013-05-01 | All One, Inc. | Class II | Labeling, manufacturing, potency or other | Product label misprinted to include claim of "No Dairy", even though milk is present in an ingredient (calcium caseinate). "Certified Vegan" is also claimed on the product label. The side panel discusses the presence of milk in the product. F-1340-2013 |
| 2013-05-01 | Brower Enterprises Inc | Class I | Undeclared drug ingredient | Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary Supplement, because it contains undeclared drug ingredients making it an unapproved drug. FDA sample analysis has found the product to contain methocarbamol, dexamethasone, and diclofenac. D-267-2013 |
| 2013-04-17 | F.H.G Corporation dba Integrity Nutraceuticals | Class II | Labeling, manufacturing, potency or other | One lot of each product may have extraneous materials due to a problem on the packing line. F-1298-2013 |
| 2013-04-17 | Magno Humphries Inc | Class III | Contaminants, adulteration or foreign material | The firm found minute pieces of blue material identified by their raw material supplier as polypropylene, a relatively inert plastic. F-1304-2013 |
| 2013-04-17 | F.H.G Corporation dba Integrity Nutraceuticals | Class II | Labeling, manufacturing, potency or other | One lot of each product may have extraneous materials due to a problem on the packing line. F-1297-2013 |
| 2013-04-17 | New Chapter, Inc. | Class I | Undeclared allergen | The product may contain an undeclared allergen soy F-1299-2013 |
| 2013-03-27 | NBTY Inc. | Class III | Potency, dissolution or quality defect | The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage. F-1225-2013 |
| 2013-03-27 | Wynlife Healthcare, Inc. | Class II | Contaminants, adulteration or foreign material | Wynlife healthcare is recalling their All-In-One Probiotics and Vegi-Fiber Plus products due to DEHP contaminated clouding agents. F-1243-2013 |
| 2013-03-27 | Pascalite, Incorporated | Class II | Contaminants, adulteration or foreign material | Pascalite is recalling internally used pascalite powder products because they may contain violative levels of lead. F-1127-2013 |
| 2013-03-27 | NBTY Inc. | Class III | Potency, dissolution or quality defect | The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage. F-1224-2013 |
| 2013-03-27 | Wynlife Healthcare, Inc. | Class II | Contaminants, adulteration or foreign material | Wynlife healthcare is recalling their All-In-One Probiotics and Vegi-Fiber Plus products due to DEHP contaminated clouding agents. F-1244-2013 |
| 2013-03-27 | NBTY Inc. | Class III | Potency, dissolution or quality defect | The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage. F-1223-2013 |
| 2013-03-27 | Pascalite, Incorporated | Class II | Contaminants, adulteration or foreign material | Pascalite is recalling internally used pascalite powder products because they may contain violative levels of lead. F-1126-2013 |
| 2013-03-20 | A B Nutrition, Inc. | Class II | Unapproved drug claims or misbranding | Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. D-194-2013 |
| 2013-03-20 | A B Nutrition, Inc. | Class II | Unapproved drug claims or misbranding | Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. D-195-2013 |
| 2013-03-20 | A B Nutrition, Inc. | Class II | Unapproved drug claims or misbranding | Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug. D-196-2013 |
| 2013-02-13 | NBTY Inc. | Class III | Labeling, manufacturing, potency or other | Acetobacter lovaniensis was detected in a sample of the product tested by a private laboratory. This is an issue of commercial spoilage. F-0980-2013 |
| 2013-02-06 | EonNutra, LLC | Class II | Microbial contamination | Eon Nutra, LLC is recalling certain SOTO Supplements GFC 200 because the liquid dietary supplement products may be contaminated with various types of bacteria. F-0937-2013 |
| 2013-01-16 | Lifevantage Corp | Class II | Contaminants, adulteration or foreign material | Possible inclusion of small metal fragments embedded within the tablets of Protandim Dietary Supplement. F-0876-2013 |
| 2012-11-07 | Botanical Laboratories Inc | Class I | Microbial contamination | Product ("Digestive 3 in 1 Health") was manufactured using a raw ingredient that tested positive for Salmonella by the raw ingredient supplier. F-0594-2013 |
| 2012-11-07 | XRock Industries, LLC | Class I | Undeclared drug ingredient | Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED). D-037-2013 |
| 2012-09-26 | Protica, Inc | Class II | Microbial contamination | Product not sufficiently acidified (equilibrium pH higher than 4.6), therefore it has the potential to be contaminated with Clostridium botulinum F-2350-2012 |
| 2012-09-26 | GMP Laboratories of America Inc | Class II | Labeling, manufacturing, potency or other | The firm recalled because the product lot contained mispackaged product wherein some capsules were missing from the finished packaged product. F-2297-2012 |
| 2012-09-26 | Protica, Inc | Class II | Microbial contamination | Product not sufficiently acidified (equilibrium pH higher than 4.6), therefore it has the potential to be contaminated with Clostridium botulinum F-2349-2012 |
| 2012-09-19 | Atlas Operations, Inc. | Class II | Microbial contamination | Atlas Operations, Inc is recalling Meal Replacement foru Dietary Supplement, Lot R2-981-12, Exp. Date: 7/14 for possible microbial contamination. F-2292-2012 |
| 2012-08-08 | Defense Nutrition | Class III | Undeclared allergen | The products contain undeclared soy lecithin F-1814-2012 |
| 2012-08-08 | Defense Nutrition | Class III | Undeclared allergen | The products contain undeclared soy lecithin F-1813-2012 |
| 2012-08-08 | Defense Nutrition | Class III | Undeclared allergen | The products contain undeclared soy lecithin F-1815-2012 |
| 2012-07-25 | Nutri-Health Supplements Llc. | Class I | Microbial contamination | On the evening of Friday, July 6, 2012, Ingredion, Inc. (f/k/a Corn Products U.S., Inc.) the supplier of Galactooligosaccharide (GOS), an ingredient included, in iFlora¿ Kids Multi Probiotic, notified our contract manufacturer that two lots of their GOS material supplied for inclusion in our products were being recalle F-1771-2012 |
| 2012-07-25 | Standard Process, Inc. | Class I | Microbial contamination | Standard Process, Inc. is voluntarily recalling 3 dietary supplements due to potential Salmonella contamination. F-1765-2012 |
| 2012-07-25 | Standard Process, Inc. | Class I | Microbial contamination | Standard Process, Inc. is voluntarily recalling 3 dietary supplements due to potential Salmonella contamination. F-1764-2012 |
| 2012-07-04 | PGP International, Inc. | Class II | Undeclared allergen | The product contains undeclared wheat. F-1654-2012 |
Brand pages
115 of the records name a firm whose name, after dropping punctuation and a trailing "LLC" or "Inc.", equals the name of a DSLD brand (57 brands, with 4,941 on-market products between them). Those records appear on the matching brand's page. The match is by name only, so it says the firm shares a name with the brand, not that any particular product of that brand was recalled; read the product and reason in the record.
What this does not show
- It is not a ranking of brands. Large brands sell more products and are inspected and tested more, and most recalls are voluntary and firm-initiated; a recall can also mean a firm found and fixed a problem.
- It is incomplete. We only keep records whose description says "dietary supplement" or "nutritional supplement". Others, such as products described only as a vitamin or by brand name, are missed, and a firm or UPC we cannot match is simply absent here.
- It is a snapshot. The FDA updates records as recalls progress and terminates them when complete; the status you see on the FDA record is the current one.
- It is not medical or safety advice. If you have a product you are worried about, check its lot number against the FDA's recall notice and talk to a pharmacist or physician.
Source: FDA openFDA enforcement API, food and drug endpoints, public-domain US government data. openFDA states its data is unvalidated and is not for medical decisions.