Browse Drug Recalls

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 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 17,874 FDA drug recalls.

DateProductReasonClassFirm
Apr 20, 2023 G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric... Product mix-up: incorrect product was found inside the G-Supress DX product carton. Class I Novis PR, LLC dba Kramer Novis
Apr 19, 2023 Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Ster... Presence of Particulate Matter: A piece of glass was found in a prefilled syringe. Class II Sun Pharmaceutical Industries Ltd.
Apr 19, 2023 Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Sol... Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the label... Class II Seatex LLC
Apr 13, 2023 Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.... Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... Class III DuPont Nutrition USA, Inc
Apr 13, 2023 Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / ... Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... Class III DuPont Nutrition USA, Inc
Apr 13, 2023 Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.... Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... Class III DuPont Nutrition USA, Inc
Apr 13, 2023 Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.... Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... Class III DuPont Nutrition USA, Inc
Apr 13, 2023 C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder ... Lack of assurance of sterility. Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Apr 11, 2023 Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial,... Lack of Assurance of Sterility: Malformed crimped collar seal Class II Sanofi-Aventis U.S. LLC
Apr 10, 2023 Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose ... Subpotent Drug: Out of specification results for low potency was obtained. Class III SCA Pharmaceuticals
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, 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.
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 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.
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 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) 24-count ... 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 29, 2023 Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multipl... Sub-potent drug: assay test result below specifications at 9-month timepoint. Class III Accord Healthcare, Inc.
Mar 29, 2023 Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-d... Failed Impurities/Degradation Specifications: Above the specification limits yielded for related ... Class III SUN PHARMACEUTICAL INDUSTRIES INC
Mar 27, 2023 Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip ... Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect. Class III Pine Pharmaceuticals, LLC
Mar 27, 2023 Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solutio... Chemical Contamination: FDA testing found Presence of methanol Class I Jarman's Midwest Cleaning Systems, Inc.
Mar 27, 2023 SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STER... Chemical Contamination: FDA testing found Presence of methanol Class I Jarman's Midwest Cleaning Systems, Inc.
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 Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 3... Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A. Class III Teva Pharmaceuticals USA 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 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 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 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 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 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 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 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 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 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 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 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, 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 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 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 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 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 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

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.