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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.