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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.