Browse Drug Recalls

1,020 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,020 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 1,020 FDA drug recalls.

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DateProductReasonClassFirm
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 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 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 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 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 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 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 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 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 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 Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Man... Failed Impurities/Degradation Specifications; 18 month long term stability study. Class III Lupin Pharmaceuticals Inc.
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 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 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 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 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 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 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 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 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 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 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 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 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 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.
Mar 28, 2019 Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx on... Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was ob... Class III Akorn, Inc.
Mar 22, 2019 Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg,... Failed Impurities/Degradation Specifications: Out-of-specification results observed in related su... Class II Lupin Pharmaceuticals Inc.
Mar 12, 2019 Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, ... Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testi... Class II Akorn Inc
Mar 7, 2019 Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tabl... Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stabili... Class III Boehringer Ingelheim Pharmaceuticals, Inc.
Mar 1, 2019 Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules... Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity... Class II American Health Packaging
Feb 28, 2019 BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 coun... Failed Dissolution Specifications; 9-monthstability timepoint Class III Jubilant Cadista Pharmaceuticals, Inc.
Feb 22, 2019 Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, M... Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed du... Class II Ascend Laboratories LLC
Feb 22, 2019 Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manu... Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individ... Class II Akorn, Inc.
Feb 13, 2019 Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count ... Failed Impurities/Degradation Specifications: High out of specification results obtained during r... Class III Mylan Pharmaceuticals Inc.
Feb 13, 2019 Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, ... Failed Degradation/Impurities Specifications: Out of specification related substance results duri... Class III Perrigo New York, Inc.
Feb 4, 2019 Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl... Failed Stability Specification: out of specification results for Sodium Perborate Class II Akorn Inc
Feb 1, 2019 Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Man... Failed Impurities/Degradation Specifications: Out of specification test results in related substa... Class III Lupin Pharmaceuticals Inc.
Jan 25, 2019 Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) an... Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month ... Class III Akorn Inc
Jan 18, 2019 Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for... Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected durin... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jan 18, 2019 Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0... Failed Impurities/Degradation Specifications: Related compound results obtained during routine st... Class II Mylan Pharmaceuticals Inc.
Dec 20, 2018 COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol ... Failed Stability Specifications: out of specification results for opalescence at 7 month stabilit... Class III Akorn Inc
Dec 10, 2018 Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx... Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification ... Class II Dr. Reddy's Laboratories, Inc.
Nov 8, 2018 INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx ... Failed Stability Specification: out of specification for iron content. Class II ALLERGAN
Nov 7, 2018 Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx... Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 1... Class II Dr. Reddy's Laboratories, Inc.
Nov 6, 2018 Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Di... Failed Stability Specifications: Out-of-Specification results obtained for particle size distribu... Class III Breckenridge Pharmaceutical, Inc.
Nov 6, 2018 AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by:... Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month ... Class III Takeda Development Center Americas, Inc.
Oct 26, 2018 Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifes... Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability... Class III RemedyRepack Inc.
Oct 22, 2018 Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only,... Failed Dissolution Specifications: OOS resultsduring routine stability testing Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 19, 2018 Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, R... Failed dissolution specifications: Out-of-Specification dissolution test result obtained during r... Class II Teva Pharmaceuticals USA
Oct 19, 2018 Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, ... Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit wa... Class II Taro Pharmaceuticals U.S.A., 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.