Browse Drug Recalls

1,122 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,122 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 1,122 FDA drug recalls in 2023.

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DateProductReasonClassFirm
Feb 7, 2023 Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle,... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufac... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, ND... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactur... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufa... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 167... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, R... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-1... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Acc... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 1... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bott... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 7, 2023 Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured ... CGMP Deviations: recalling drug products following an FDA inspection. Class II Accord Healthcare, Inc.
Feb 6, 2023 Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Ma... Sub-Potent Drug: Out of specification for assay at the 24 month interval. Class II Alvogen, Inc
Feb 3, 2023 Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx on... Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus. Class II Leadiant Biosciences, Inc.
Feb 2, 2023 Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First ai... Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing. Class III Advantice Health, Llc
Feb 1, 2023 BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., Net Content/Gross W... Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... Class III DuPont Nutrition USA, Inc
Feb 1, 2023 Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/... Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... Class III DuPont Nutrition USA, Inc
Feb 1, 2023 Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/... Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... Class III DuPont Nutrition USA, Inc
Feb 1, 2023 Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/G... Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... Class III DuPont Nutrition USA, Inc
Jan 31, 2023 Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manuf... Failed Impurities/Degradation Specifications: High Out Of Specification degradation results. Class II BIOCON PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 microgram/mL; 6 pouc... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouc... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG i... Non-Sterility: FDA analysis found unopened products to have bacterial contamination. Class I Global Pharma Healthcare Private Limited
Jan 30, 2023 Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Ey... Non-Sterility: FDA analysis found unopened products to have bacterial contamination. Class I Global Pharma Healthcare Private Limited
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouch... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 microgram/mL; 6 pouc... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL; 6 pou... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pou... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG i... CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because th... Class II Global Pharma Healthcare Private Limited
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouc... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL; 6 pou... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The ... Failed Stability Specifications: Out of specification test results for viscosity was identified a... Class III Akorn, Inc.
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL; 6 pou... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Ey... CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because th... Class II Global Pharma Healthcare Private Limited
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL; 6 pouch... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouc... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouch... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL; 6 pouc... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouch... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouch... Subpotent Drug Class II IBSA PHARMA INC
Jan 27, 2023 Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 T... Failed Dissolution Specification: Out of specification dissolution results at time point zero. Th... Class II Amerisource Health Services LLC

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.