Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Nov 17, 2020 ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, M... FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits f... Class II Golden State Medical Supply Inc.
Nov 17, 2020 CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET ... Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight... Class II Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020 Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g), D... Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight... Class II Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020 Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (2... Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight... Class II Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020 Equate Athlete's Foot, Clotrimazole USP 1%, Antifungal Cream, Packaged as a) ... Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight... Class II Taro Pharmaceuticals U.S.A., Inc.
Nov 17, 2020 H-E-B - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal NET WT. 0.... Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slight... Class II Taro Pharmaceuticals U.S.A., Inc.
Nov 11, 2020 Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, ND... Failed Dissolution Specifications: Out of specification for dissolution. Class II Apotex Corp.
Nov 10, 2020 Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Man... Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle o... Class II EYWA PHARMA INC
Nov 6, 2020 clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Man... Failed Tablet/Capsule Specification Class II Jubilant Cadista Pharmaceuticals, Inc.
Nov 3, 2020 Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, ... Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Inje... Class II Hikma Pharmaceuticals USA Inc.
Nov 1, 2020 Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage X... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acce... Class II Preferred Pharmaceuticals, Inc.
Oct 30, 2020 Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bo... Failed Dissolution Specifications Class II AVKARE Inc.
Oct 28, 2020 Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx ... Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during ... Class II Teva Pharmaceuticals USA
Oct 27, 2020 Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count c... Failed Dissolution Specification Class II Zydus Pharmaceuticals (USA) Inc
Oct 27, 2020 Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count c... Failed Dissolution Specification Class II Zydus Pharmaceuticals (USA) Inc
Oct 26, 2020 Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count b... Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablet... Class II Ascent Pharmaceuticals, Inc.
Oct 23, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottl... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II Nostrum Laboratories Inc
Oct 23, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottl... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II Nostrum Laboratories Inc
Oct 21, 2020 White Liniment packaged in a) 1 oz; b) 4 oz.; and c) 6 oz bottles. Mfg & Sold... CGMP Deviations Class II H & H Remedies, LLC
Oct 21, 2020 Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. M... CGMP Deviations Class II H & H Remedies, LLC
Oct 21, 2020 Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 1... CGMP Deviations Class II H & H Remedies, LLC
Oct 12, 2020 Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Daw... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II Direct Rx
Oct 11, 2020 Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx o... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II RemedyRepack Inc.
Oct 9, 2020 MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottl... GMP Deviations Class II Milbar Laboratories, Inc.
Oct 9, 2020 DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatol... GMP Deviations Class II Milbar Laboratories, Inc.
Oct 9, 2020 DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%) 300 ml/10.1 fl.oz. Dermatolo... GMP Deviations Class II Milbar Laboratories, Inc.
Oct 9, 2020 (Malin + Goetz) Salicylic Gel (2% Salicylic Acid) 0.5 fl.oz. 15 mL tube, Dist... GMP Deviations Class II Milbar Laboratories, Inc.
Oct 9, 2020 (Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octino... GMP Deviations Class II Milbar Laboratories, Inc.
Oct 9, 2020 Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, D... GMP Deviations Class II Milbar Laboratories, Inc.
Oct 9, 2020 N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bo... Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap. Class II Jarrow Formulas Inc
Oct 9, 2020 DCL B Prox10 Anti-Blemish Wash (Benzoyl Peroxide 10%), 200 ml/6.7 fl.oz. Derm... GMP Deviations Class II Milbar Laboratories, Inc.
Oct 9, 2020 DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmeti... GMP Deviations Class II Milbar Laboratories, Inc.
Oct 9, 2020 DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatolog... GMP Deviations Class II Milbar Laboratories, Inc.
Oct 9, 2020 DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz, De... GMP Deviations Class II Milbar Laboratories, Inc.
Oct 9, 2020 DCL T Shampoo for Hair and Body ( Solution Coal Tar U.S.P. 3% and 0.6% Coal T... GMP Deviations Class II Milbar Laboratories, Inc.
Oct 9, 2020 Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics GMP Deviations Class II Milbar Laboratories, Inc.
Oct 9, 2020 Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads GMP Deviations Class II Milbar Laboratories, Inc.
Oct 9, 2020 (Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis (1.9% P... GMP Deviations Class II Milbar Laboratories, Inc.
Oct 8, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (ND... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II Denton Pharma, Inc.
Oct 8, 2020 Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottl... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II Denton Pharma, Inc.
Oct 7, 2020 Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 m... Presence of particulate matter in solution - black and transparent particles Class II Baxter Healthcare Corporation
Oct 6, 2020 metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Ok... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II PD-Rx Pharmaceuticals, Inc.
Oct 6, 2020 metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: ... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II PD-Rx Pharmaceuticals, Inc.
Oct 5, 2020 Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx... An extraneous peak was observed for dissolution testing. Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 5, 2020 Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx... An extraneous peak was observed for dissolution testing. Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 5, 2020 Catapres (clonidine hydrochloride, USP) 0.2 mg, tablet, 100-count bottle, Rx... An extraneous peak was observed for dissolution testing. Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Oct 2, 2020 Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 ... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II Marksans Pharma Limited
Oct 2, 2020 Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0 Discoloration. Class II Medichem S.A.
Oct 2, 2020 Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II Marksans Pharma Limited
Sep 24, 2020 SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL O... CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... Class II AA PRODUCTS 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.