Browse Drug Recalls
3,430 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,430 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 3,430 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 2, 2019 | DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Si... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| May 2, 2019 | CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moi... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| May 2, 2019 | CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pin... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| May 2, 2019 | CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| May 2, 2019 | CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorph... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| May 2, 2019 | DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guai... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| May 2, 2019 | DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar P... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| May 1, 2019 | Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Golden State Medical Supply Inc. |
| May 1, 2019 | Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx on... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Golden State Medical Supply Inc. |
| May 1, 2019 | Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx o... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Golden State Medical Supply Inc. |
| May 1, 2019 | Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx onl... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Golden State Medical Supply Inc. |
| May 1, 2019 | Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Golden State Medical Supply Inc. |
| Apr 30, 2019 | Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distribute... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Direct Rx |
| Apr 30, 2019 | Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and ... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Preferred Pharmaceuticals, Inc |
| Apr 24, 2019 | Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC ... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | AVKARE Inc. |
| Apr 24, 2019 | Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC ... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | AVKARE Inc. |
| Apr 24, 2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distribut... | CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found ... | Class II | Legacy Pharmaceutical Packaging LLC |
| Apr 24, 2019 | DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-un... | cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. | Class II | MAJOR PHARMACEUTICALS |
| Apr 22, 2019 | Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 m... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with T... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soa... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 05857... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) ... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE San... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Fo... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium ch... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | RemedyRepack Inc. |
| Apr 18, 2019 | Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Apr 18, 2019 | Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)10... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Apr 18, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-c... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Apr 18, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-co... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Apr 18, 2019 | Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)10... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Apr 18, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Apr 11, 2019 | Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (... | cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. | Class II | Dr. Reddy's Laboratories, Inc. |
| Apr 1, 2019 | DIPPIN' DOTS SCENTED COTTON CANDY ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%),... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | TOOTSIE ROLL FRUIT CHEWS LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 6... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | ICEE CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / ... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | ICEE BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 ... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | TOOTSIE ROLL FRUIT CHEWS VANILLA SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcoho... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | DOTS SCENTED ANTIBACTERIAL HAND GEL LEMON (Ethyl Alcohol 62%), 1.35 fl oz / 4... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | CHARMS BLOW POP WATERMELON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%)... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | AIR HEADS BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), ... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | AIR HEADS STRAWBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | Good to Go Hand Sanitizer (Ethyl Alcohol 62%), 1 FL OZ (30 mL), OTC, Made in ... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | DIPPIN' DOTS SCENTED COOKIES 'N CREAM ANTIBACTERIAL HAND GEL (Ethyl Alcohol 6... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | TOOTSIE ROLL FRUIT CHEWS LEMON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol ... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
Frequently Asked Questions
When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.