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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 7, 2025 | Voriconazole Container Description: voriconazole The product packed in white ... | CGMP Deviations | Class II | Aspen Biopharma Labs Pvt., Ltd. |
| Feb 7, 2025 | Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle | CGMP Deviations | Class II | Aspen Biopharma Labs Pvt., Ltd. |
| Feb 7, 2025 | Bimatoprost NDC# 82187-1001-1 Container description: The product packed in ... | CGMP Deviations | Class II | Aspen Biopharma Labs Pvt., Ltd. |
| Feb 7, 2025 | Alprostadil Container Description: Amber color bottle | CGMP Deviations | Class II | Aspen Biopharma Labs Pvt., Ltd. |
| Feb 7, 2025 | Finasteride NDC# 82187-1003-1 Container Description: The product packed in w... | CGMP Deviations | Class II | Aspen Biopharma Labs Pvt., Ltd. |
| Feb 7, 2025 | Chlorambucil Container Description: The product packed in double self-seal co... | CGMP Deviations | Class II | Aspen Biopharma Labs Pvt., Ltd. |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured ... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured ... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 24, 2025 | Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister car... | CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended a... | Class II | RemedyRepack Inc. |
| Jan 22, 2025 | Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) ... | CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 22, 2025 | Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b... | CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 17, 2025 | Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL... | cGMP Deviations: Product intended for quarantine was inadvertently distributed. | Class II | McKesson |
| Jan 13, 2025 | Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses ... | CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Dulo... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Dec 30, 2024 | Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Dis... | CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Class II | Rising Pharma Holding, Inc. |
| Dec 30, 2024 | Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000... | CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Class II | Rising Pharma Holding, Inc. |
| Dec 30, 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. |
| Dec 23, 2024 | First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla,... | CGMP Deviations; product intended for quarantine was inadvertently distributed | Class II | First Aid Beauty Ltd |
| Dec 18, 2024 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only... | CGMP Deviations | Class II | Eugia US LLC |
| Dec 12, 2024 | Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured... | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit | Class II | Ascend Laboratories, LLC |
| Dec 12, 2024 | Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured... | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit | Class II | Ascend Laboratories, LLC |
| Dec 11, 2024 | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, ... | CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 11, 2024 | chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, M... | CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per... | Class II | Glenmark Pharmaceuticals Inc., USA |
| 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 | 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 | 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 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, 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, 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, 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 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 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, 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 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, 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 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 | 10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your R... | CGMP Deviations: Inconsistency in the water systems. | Class II | Generitech Corporation |
| 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. |
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.