Browse Drug Recalls

3,368 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,368 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 3,368 FDA drug recalls.

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DateProductReasonClassFirm
Apr 26, 2023 Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, Fo... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Ak... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Op... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distribute... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured b... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tub... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, pack... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 7, 2023 Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For... CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inven... Class II Methapharm Inc
Apr 6, 2023 Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India ... CGMP deviations. Class II PD-Rx Pharmaceuticals, Inc.
Apr 6, 2023 Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India ... CGMP deviations. Class II PD-Rx Pharmaceuticals, Inc.
Apr 6, 2023 Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 m... CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation. Class II Pharma Nobis LLC
Apr 6, 2023 Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India... CGMP deviations. Class II PD-Rx Pharmaceuticals, Inc.
Apr 6, 2023 Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limite... CGMP deviations. Class II PD-Rx Pharmaceuticals, Inc.
Apr 6, 2023 Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By... CGMP deviations. Class II PD-Rx Pharmaceuticals, Inc.
Mar 31, 2023 Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever R... CGMP deviation: product outside labeled storage temperature requirements. Class II Family Dollar Stores, Llc.
Mar 31, 2023 Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged ... CGMP deviation: product outside labeled storage temperature requirements. Class II Family Dollar Stores, Llc.
Mar 31, 2023 Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAI... CGMP deviation: product outside labeled storage temperature requirements. Class II Family Dollar Stores, Llc.
Mar 31, 2023 Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count ... CGMP deviation: product outside labeled storage temperature requirements. Class II Family Dollar Stores, Llc.
Mar 27, 2023 Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-... CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... Class II Preferred Pharmaceuticals, Inc.
Mar 27, 2023 Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-steril... CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of met... Class II Jarman's Midwest Cleaning Systems, Inc.
Mar 27, 2023 Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-75... CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... Class II Preferred Pharmaceuticals, Inc.
Mar 27, 2023 Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharma... CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Acco... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accor... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: ... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufacture... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (ND... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC ... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Acc... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accor... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: ... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactu... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2023 Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord... cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. Class II Preferred Pharmaceuticals, Inc.
Mar 22, 2023 Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distribute... CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns... Class II Direct Rx
Mar 22, 2023 Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed ... CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns... Class II Direct Rx
Mar 22, 2023 Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b... CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns... Class II Direct Rx
Mar 20, 2023 Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged ... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRep... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRep... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) ... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRep... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01... cGMP Deviations Class II RemedyRepack Inc.
Mar 20, 2023 Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-0... cGMP Deviations Class II RemedyRepack 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.