Browse Drug Recalls

3,458 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,458 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 3,458 FDA drug recalls.

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DateProductReasonClassFirm
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.
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.

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.