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 |
|---|---|---|---|---|
| Apr 1, 2019 | CHARMS BLOW POP CHERRY 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. |
| Apr 1, 2019 | SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, ... | 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 ORANGE 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. |
| Apr 1, 2019 | Tootsie Roll POP CHOCOLATE 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 | Tootsie Roll POP 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 PINK LEMONADE 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. |
| Apr 1, 2019 | AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | AMERICA'S ORIGINAL DUBBLE BUBBLE 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 ORANGE (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 | Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl... | 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 SOUR APPLE 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 | Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcoh... | 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 BLUE RAZZ BERRY 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 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 | DOTS SCENTED ANTIBACTERIAL HAND GEL STRAWBRRY (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 | DIPPIN' DOTS SCENTED BIRTHDAY CAKE 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 | DIPPIN' DOTS SCENTED BANANA SPLIT 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 ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl ... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | ICEE LEMON LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl o... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ing... | 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 LIME (Ethyl Alcohol 62%), 1.35 fl oz / 40... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | ICEE PEACH SCENTED ANTIBACTERIAL HAND GEL (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. |
| Mar 19, 2019 | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%... | cGMP Deviations | Class II | Allergan Sales, LLC |
| Mar 14, 2019 | Losartan 50mg Tablet, 30 count each blister card. | CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmace... | Class II | RemedyRepack Inc. |
| Mar 12, 2019 | Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx D... | CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in th... | Class II | Direct Rx |
| Mar 8, 2019 | Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorpo... | CGMP deviation: Product found to contain trace amounts of NMBA | Class II | PD-Rx Pharmaceuticals, Inc. |
| Mar 7, 2019 | Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Ace... | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... | Class II | Rising Pharmaceuticals, Inc. |
| Mar 7, 2019 | Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Heal... | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... | Class II | Rising Pharmaceuticals, Inc. |
| Mar 7, 2019 | Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Ace... | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... | Class II | Rising Pharmaceuticals, Inc. |
| Mar 7, 2019 | Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Ace... | CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA)... | Class II | Rising Pharmaceuticals, Inc. |
| Mar 6, 2019 | Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, ... | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the... | Class II | American Health Packaging |
| Mar 6, 2019 | Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-0... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified. | Class II | Preferred Pharmaceuticals, Inc |
| Mar 5, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tab... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified | Class II | AVKARE Inc. |
| Mar 5, 2019 | Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx On... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified | Class II | AVKARE Inc. |
| Mar 5, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tabl... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified | Class II | AVKARE Inc. |
| Mar 4, 2019 | Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 m... | CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found ... | Class II | H J Harkins Company Inc dba Pharma Pac |
| Mar 1, 2019 | Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distrib... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Class II | Legacy Pharmaceutical Packaging LLC |
| Mar 1, 2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distribut... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected. | Class II | Legacy Pharmaceutical Packaging LLC |
| Mar 1, 2019 | Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distribut... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Class II | Legacy Pharmaceutical Packaging LLC |
| Mar 1, 2019 | Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distribut... | CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected | Class II | Legacy Pharmaceutical Packaging LLC |
| Feb 28, 2019 | Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30... | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the ... | Class II | Camber Pharmaceuticals Inc |
| Feb 28, 2019 | Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-3... | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the ... | Class II | Camber Pharmaceuticals Inc |
| Feb 28, 2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-co... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 28, 2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-coun... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 28, 2019 | Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90... | CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the ... | Class II | Camber Pharmaceuticals Inc |
| Feb 28, 2019 | LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) ... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 28, 2019 | LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 9... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 28, 2019 | LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 28, 2019 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-cou... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) i... | Class II | Torrent Pharma Inc. |
| Feb 21, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 coun... | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the... | Class II | Macleods Pharma Usa Inc |
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.