Browse Drug Recalls

1,056 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,056 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 1,056 FDA drug recalls.

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DateProductReasonClassFirm
Jun 9, 2021 Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For... Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content we... Class II Genentech Inc
May 14, 2021 Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-... Presence of Foreign Substance: Foreign particles observed during routine stability testing. Class II Teligent Pharma, Inc.
Mar 29, 2021 Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent... Failed Stability Specifications: product did not meet viscosity results. Class III Teligent Pharma, Inc.
Mar 19, 2021 Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only,... Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown i... Class II Golden State Medical Supply Inc.
Mar 19, 2021 Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, M... Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological ... Class II X-Gen Pharmaceuticals Inc.
Mar 11, 2021 Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only,... Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown i... Class II Breckenridge Pharmaceutical, Inc
Mar 8, 2021 Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose... Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed ... Class II Akorn, Inc.
Mar 4, 2021 Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Phar... Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities... Class III Teva Pharmaceuticals USA
Feb 26, 2021 Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Di... Failed Dissolution Specifications: Out-of-specification results observed for dissolution during s... Class II Dr. Reddy's Laboratories, Inc.
Jan 21, 2021 Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume afte... Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impu... Class III Lupin Pharmaceuticals Inc.
Jan 7, 2021 Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured ... Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t... Class III Bausch Health Companies, Inc.
Jan 7, 2021 Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceansi... Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t... Class III Bausch Health Companies, Inc.
Dec 18, 2020 Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, R... Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide i... Class III KVK-Tech, Inc.
Nov 20, 2020 Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceutic... Subpotency: Out-of-specification stability test result for low potency was obtained. Class III SCA Pharmaceuticals
Nov 11, 2020 Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, ... Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5... Class III InvaTech Pharma Solutions, LLC
Nov 11, 2020 Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose ... Superpotent Drug: High out-of-specification assay results were obtained during stability testing. Class III Teva Pharmaceuticals USA
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 23, 2020 Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Dis... Failed impurities/ degradation specifications: Out of specification impurity results were observe... Class III Heritage Pharmaceuticals Inc
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.
Sep 16, 2020 Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. In... cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. Class II Calvin Scott & Company, Inc.
Sep 16, 2020 Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc.... cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. Class II Calvin Scott & Company, Inc.
Sep 16, 2020 Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. In... cMGP Deviations: Drug products repackaged into pouches without supporting stability studies. Class II Calvin Scott & Company, Inc.
Sep 9, 2020 Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg... Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9... Class III PAI Holdings, LLC. dba Pharmaceutical Associate...
Sep 4, 2020 Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal... Failed Stability Specifications: Below specification result for buprenorphine release rate. Class II Teva Pharmaceuticals USA
Aug 14, 2020 Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intra... Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing. Class II Hikma Pharmaceuticals USA Inc.
Aug 10, 2020 Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Ave... Failed Stability Specifications: Out of Specification result for enzyme activity levels noted dur... Class II Sanofi-Aventis U.S. LLC
Aug 3, 2020 Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine ... Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... Class III Ultra Seal Corporation
Aug 3, 2020 Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65... Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... Class III Ultra Seal Corporation
Jul 29, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), ... Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. Class II SCA Pharmaceuticals
Jul 6, 2020 Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx ... Cross contamination with other products - OOS discovered during routine stability testing for hig... Class III SUN PHARMACEUTICAL INDUSTRIES INC
Jun 29, 2020 Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repacka... FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained dur... Class II RemedyRepack Inc.
Jun 16, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), ... Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. Class II SCA Pharmaceuticals
May 14, 2020 Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: ... Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-ter... Class III InvaGen Pharmaceuticals, Inc.
May 5, 2020 Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only,... Discoloration: Out-of-specification results for appearance obtained during routine stability test... Class II Mylan Institutional LLC
Apr 24, 2020 Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per un... Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine st... Class III The Harvard Drug Group
Apr 18, 2020 Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Dupl... Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Pol... Class I B. Braun Medical Inc
Apr 15, 2020 Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin... Subpotent Drug: low out of specification (OOS) test result observed in long term stability study. Class II Lupin Pharmaceuticals Inc.
Mar 19, 2020 DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECT... Failed Stability Specifications Class II Jubilant Draximage Inc
Feb 24, 2020 Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous ... Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impuritie... Class III Breckenridge Pharmaceutical, Inc
Feb 20, 2020 Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only,... Failed Dissolution Specifications: Low out of specification dissolution result observed during st... Class II Teva Pharmaceuticals USA
Feb 12, 2020 Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, R... Failed Dissolution Specifications: Low out of specification results observed in dissolution test ... Class II Lupin Pharmaceuticals Inc.
Dec 13, 2019 Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-coun... Failed Dissolution Specifications: High out of specification result observed at stability studies. Class III The Harvard Drug Group
Dec 10, 2019 Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-co... Failed Dissolution Specifications: High out of specification result observed at stability studies. Class III Lupin Pharmaceuticals Inc.
Dec 4, 2019 Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister card... Failed Dissolution Specifications: Low out of specification results obtained during stability tes... Class II American Health Packaging
Nov 4, 2019 Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.... Presence of foreign substance: Brown/black particles found during stability testing. Class II Teva Pharmaceuticals USA, Inc.
Oct 30, 2019 Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceu... Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron con... Class II Avantor Performance Materials Inc
Sep 6, 2019 Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in... Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities de... Class II Torrent Pharma Inc.
Aug 28, 2019 AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Table... Failed Stability Specifications. Class II AVKARE Inc.
Aug 21, 2019 Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufa... Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride... Class III Macleods Pharma Usa Inc
Jul 17, 2019 Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tub... Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of c... Class III Lupin Pharmaceuticals 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.