Browse Drug Recalls

1,720 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,720 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 1,720 FDA drug recalls, Class III.

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DateProductReasonClassFirm
Jun 21, 2022 Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsu... Superpotent Drug: Out of specification for assay at the 12-month timepoint. Class III SUN PHARMACEUTICAL INDUSTRIES INC
Jun 16, 2022 Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC ... Defective Container Class III Glenmark Pharmaceuticals Inc., USA
Jun 3, 2022 Olopatadine HCl, Ophthalmic Solution, USP, 0.2%, 2.5 mL per dropper bottle, R... Failed impurity/degradation specifications: Out of specification for 2-HMP (a product leachable) ... Class III Akorn, Inc.
May 18, 2022 Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Cart... Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtaine... Class III Teva Pharmaceuticals USA Inc
May 13, 2022 Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured ... Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was print... Class III GlaxoSmithKline LLC
May 10, 2022 Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in ... Failed Impurities/Degradation Specifications. Class III Novartis Pharmaceuticals Corporation
May 10, 2022 Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in ... Failed Impurities/Degradation Specifications. Class III Novartis Pharmaceuticals Corporation
May 10, 2022 Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Con... Failed Impurities/Degradation Specifications. Class III Novartis Pharmaceuticals Corporation
May 10, 2022 Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Contai... Failed Impurities/Degradation Specifications. Class III Novartis Pharmaceuticals Corporation
May 3, 2022 Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apo... Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded th... Class III Apotex Corp.
May 3, 2022 Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsule... Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at... Class III American Health Packaging
Apr 29, 2022 buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count b... Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance foun... Class III SUN PHARMACEUTICAL INDUSTRIES INC
Apr 29, 2022 Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25... Mislabeling: The active ingredient list on the label does not match the product's actual ingredie... Class III Eco Lips, Inc
Apr 29, 2022 buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in... Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance foun... Class III SUN PHARMACEUTICAL INDUSTRIES INC
Apr 27, 2022 Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint ... Subpotent drug: Low OOS for menthol content at the three month room temperature. Class III Bestco LLC
Apr 15, 2022 Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per b... Failed viscosity specification - product was below specificcation Class III Akorn, Inc.
Apr 14, 2022 Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Man... Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content Class III Monarch PCM, LLC
Apr 13, 2022 Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL... cGMP deviations: Temperature abuse Class III Mckesson Medical-Surgical Inc. Corporate Office
Apr 12, 2022 Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutan... Subpotent Drug: Out of specification for assay. Class III American Health Packaging
Apr 5, 2022 Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL ... Subpotent Drug: Out of Specification results for Assay Class III Aurobindo Pharma USA Inc.
Apr 1, 2022 Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured ... Subpotent Class III Jubilant Cadista Pharmaceuticals, Inc.
Apr 1, 2022 23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefille... Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bro... Class III The Ritedose Corporation
Apr 1, 2022 Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 si... Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for ... Class III SUN PHARMACEUTICAL INDUSTRIES INC
Mar 29, 2022 Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, ... Incorrect/Undeclared Excipient: Product contains alcohol Class III AptaPharma Inc.
Mar 18, 2022 NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate... Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability stud... Class III Advanced Accelerator Applications USA, Inc.
Mar 16, 2022 Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Re... Failed Impurities/Degradation Specifications: Out of Specification results for related substance. Class III Dr. Reddy's Laboratories, Inc.
Mar 10, 2022 Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured... FAILED CONTENT UNIFORMITY SPECIFICATIONS Class III Macleods Pharma Usa Inc
Mar 8, 2022 Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% S... Sub Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) ... Super Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged... Sub Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atro... Sub Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 4, 2022 Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescript... Subpotent Drug Class III Fagron, Inc
Mar 4, 2022 Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescrip... Subpotent Drug Class III Fagron, Inc
Mar 4, 2022 Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescrip... Subpotent Drug Class III Fagron, Inc
Mar 4, 2022 Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescript... Subpotent Drug Class III Fagron, Inc
Mar 4, 2022 Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescrip... Subpotent Drug Class III Fagron, Inc
Feb 25, 2022 Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, R... Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipro... Class III Taro Pharmaceuticals U.S.A., Inc.
Feb 17, 2022 Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual p... Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride pow... Class III Dr. Reddy's Laboratories, Inc.
Feb 14, 2022 Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx ... Subpotent drug Class III BayCare Integrated Service Center, LLC /dba Bay...
Jan 19, 2022 Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's ... Failed stability specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 19, 2022 Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's... Failed stability specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 19, 2022 Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Labo... Failed stability specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 10, 2022 Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, pack... Subpotent drug Class III Dr. Reddy's Laboratories, Inc.
Jan 7, 2022 Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, package... Mislabeling Class III Teva Pharmaceuticals USA
Jan 7, 2022 Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packag... Mislabeling Class III Teva Pharmaceuticals USA
Jan 4, 2022 Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Rele... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephe... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedr... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Na... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, 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.