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
Dec 10, 2024 Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ah... Crystallization Class II VIONA PHARMACEUTICALS INC
Dec 10, 2024 Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ah... Crystallization Class II VIONA PHARMACEUTICALS INC
Dec 10, 2024 LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distribu... Lack of Sterility Assurance Class II Regenerative Processing Plant, LLC
Dec 6, 2024 Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, M... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. Class II Amerisource Health Services LLC
Dec 6, 2024 Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Ma... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. Class II Amerisource Health Services LLC
Dec 6, 2024 Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (ND... CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class II Breckenridge Pharmaceutical, Inc
Dec 6, 2024 Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Ma... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. Class II Amerisource Health Services LLC
Dec 6, 2024 Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (N... CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class II Breckenridge Pharmaceutical, Inc
Dec 6, 2024 Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. Class II Amerisource Health Services LLC
Dec 6, 2024 Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobi... CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebiv... Class II Aurobindo Pharma USA Inc
Dec 5, 2024 Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx onl... Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lod... Class II FDC Limited
Dec 4, 2024 DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharma... CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso... Class II PD-Rx Pharmaceuticals, Inc.
Dec 4, 2024 Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per cart... Failed Dissolution Specifications Class II AvKARE
Dec 2, 2024 Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70... CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit. Class II RemedyRepack Inc.
Nov 27, 2024 Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE... CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinac... Class II AvKARE
Nov 27, 2024 Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE... CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinac... Class II AvKARE
Nov 27, 2024 Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE... CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinac... Class II AvKARE
Nov 26, 2024 Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit co... Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product Class II Curium US, LLC
Nov 25, 2024 Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: M... Failed Impurities/Degradation Specifications Class II Macleods Pharmaceuticals Ltd
Nov 22, 2024 VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net... CGMP deviations: out of specifications for assay Class II Apothecus Pharmaceutical Corp.
Nov 22, 2024 Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Am... Discoloration Class II Provepharm Inc.
Nov 22, 2024 Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL ... Failed Stability Specifications Class II Jubilant Draximage Inc., dba Jubilant Radiopharma
Nov 22, 2024 10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your R... CGMP Deviations: Inconsistency in the water systems. Class II Generitech Corporation
Nov 22, 2024 Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx On... Failed Impurities/Degradation Specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (... Subpotent and Superpotent Drug Class II Mylan Institutional, Inc.
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton... Subpotent and Superpotent Drug Class II Mylan Institutional, Inc.
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton... Subpotent and Superpotent Drug Class II Mylan Institutional, Inc.
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton... Subpotent and Superpotent Drug Class II Mylan Institutional, Inc.
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton... Subpotent and Superpotent Drug Class II Mylan Institutional, Inc.
Nov 19, 2024 Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton... Subpotent and Superpotent Drug Class II Mylan Institutional, Inc.
Nov 19, 2024 Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit Class II Rising Pharma Holding, Inc.
Nov 19, 2024 Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Di... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit Class II Rising Pharma Holding, Inc.
Nov 19, 2024 Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit Class II Rising Pharma Holding, Inc.
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 18, 2024 Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tab... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (ND... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (ND... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (ND... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (ND... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (N... Superpotent Drug and Subpotent Drug: potency failures obtained Class II Viatris Inc
Nov 18, 2024 Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 ta... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 18, 2024 Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablet... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 15, 2024 Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by... Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 ... Class II Evaric Pharmaceuticals Inc.
Nov 14, 2024 UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323 cGMP Deviations: the firm initiated a recall after notification from the distributor that product... Class II MXBBB

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.