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.

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DateProductReasonClassFirm
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.