Browse Drug Recalls
3,394 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,394 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 3,394 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 13, 2025 | Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured b... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: ... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b).... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manuf... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufa... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 12, 2025 | In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spec... | cGMP deviations | Class II | KABANA SKIN CARE |
| Mar 12, 2025 | B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Z... | cGMP deviations | Class II | KABANA SKIN CARE |
| Mar 12, 2025 | Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Z... | cGMP deviations | Class II | KABANA SKIN CARE |
| Mar 12, 2025 | GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Su... | cGMP deviations | Class II | KABANA SKIN CARE |
| Mar 11, 2025 | chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bo... | CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended in... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 7, 2025 | Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 6... | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... | Class II | Direct Rx |
| Mar 7, 2025 | Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: ... | CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. | Class II | Slate Run Pharmaceuticals |
| Mar 7, 2025 | Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: ... | CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. | Class II | Slate Run Pharmaceuticals |
| Mar 7, 2025 | Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distribu... | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... | Class II | Direct Rx |
| Mar 5, 2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only,... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Class II | Rising Pharma Holding, Inc. |
| Mar 5, 2025 | La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System... | cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific l... | Class II | L'Oreal USA |
| Mar 5, 2025 | La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treat... | cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific l... | Class II | L'Oreal USA |
| Mar 4, 2025 | Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, ... | CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable int... | Class II | Chattem Inc |
| Feb 28, 2025 | Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, ... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Feb 28, 2025 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, ... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Feb 28, 2025 | Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, M... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Feb 28, 2025 | Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 5... | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable inta... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Feb 28, 2025 | Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01... | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable inta... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Feb 28, 2025 | Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: G... | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable inta... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Feb 28, 2025 | Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Gl... | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable inta... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Feb 12, 2025 | ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Steri... | Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. | Class II | Wuxi Medical lnstrument Factory Co., Ltd. |
| 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 |
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.