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Browse Drug Recalls

930 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 930 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 930 FDA drug recalls in 2020.

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DateProductReasonClassFirm
Oct 9, 2020 (Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octino... 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 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, 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 DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatol... GMP Deviations Class II Milbar Laboratories, 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 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, 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 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, 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 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, 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 Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads GMP Deviations Class II Milbar Laboratories, Inc.
Oct 9, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, Inc.
Oct 9, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, Inc.
Oct 9, 2020 (Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis (1.9% P... 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 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 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 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 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 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 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 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 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 Desflurane, USP Liquid for Inhalation, 240 mL, Rx Only, Manufactured by: Sha... DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking. Class III eVenus Pharmaceutical Laboratories
Oct 5, 2020 FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL sy... Non-Sterility Class I Med Shop Total Care 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 MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syring... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in vari... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx on... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syrin... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx onl... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in v... Non-Sterility Class I Med Shop Total Care 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 5, 2020 MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syrin... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in var... Non-Sterility Class I Med Shop Total Care 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 HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes ... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx onl... Non-Sterility Class I Med Shop Total Care 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 Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, pac... Out-of-specification organic impurity results obtained during routine stability testing. Class III Mylan Pharmaceuticals Inc.
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
Oct 1, 2020 Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL),... Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleadin... Class I ASHTEL STUDIOS, INC.
Sep 28, 2020 Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-1... Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity. Class III Teligent Pharma, 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.