Browse Drug Recalls
14,136 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,136 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 14,136 FDA drug recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 24, 2025 | HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactu... | Failed Impurities/Degradation Specifications | Class II | SKY PACKAGING |
| Jan 24, 2025 | HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only... | Failed Impurities/Degradation Specifications | Class II | SKY PACKAGING |
| 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 23, 2025 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... | Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lod... | Class II | FDC Limited |
| 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 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 21, 2025 | Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 bli... | Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results we... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Jan 21, 2025 | Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blist... | Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results we... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Jan 21, 2025 | Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Man... | Out of Specification for Dissolution | Class II | AvKARE |
| Jan 21, 2025 | Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blist... | Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results we... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| 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... |
| Jan 10, 2025 | Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syrin... | Failed Stability Specifications - 12-month stability test result for one of the known peptides is... | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 8, 2025 | babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide ... | Failed stability specifications: during routine stability monitoring quality concerns were identi... | Class II | Johnson, S C and Son, Inc |
| Jan 7, 2025 | Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister card... | Presence of Foreign Tablets/Capsules | Class II | Amerisource Health Services LLC |
| 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 30, 2024 | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bot... | Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottl... | Class II | Granules Pharmaceuticals 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 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 27, 2024 | Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vi... | Presence of Particulate Matter: A market complaint was received of a glass piece in the vial. | Class II | Eugia US LLC |
| 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 23, 2024 | Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx onl... | Failed Impurities/Degradation Specifications: Out of specification results observed for the impur... | Class II | Viatris Inc |
| Dec 23, 2024 | Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx on... | Failed Impurities/Degradation Specifications: Out of specification results observed for the impur... | Class II | Viatris Inc |
| Dec 20, 2024 | Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only,... | Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug s... | Class II | Lupin Pharmaceuticals Inc. |
| Dec 19, 2024 | phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx onl... | Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attach... | Class II | Hikma Injectables USA Inc |
| Dec 19, 2024 | ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, ... | Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attach... | Class II | Hikma Injectables USA Inc |
| Dec 18, 2024 | Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granu... | Failed Dissolution Specifications: Out of specification observed during the accelerated stability... | Class II | Granules Pharmaceuticals Inc. |
| Dec 18, 2024 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only... | CGMP Deviations | Class II | Eugia US LLC |
| Dec 17, 2024 | glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) ca... | Failed Dissolution Specifications: | Class II | Amerisource Health Services LLC |
| Dec 16, 2024 | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL... | Defective container: Unable to get the solution out of the bottle as the spike of the cap was lod... | Class II | FDC Limited |
| Dec 13, 2024 | Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister card... | Presence of Foreign Tablets/Capsules | Class II | Amerisource Health Services 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 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 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 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 10, 2024 | LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distribu... | Lack of Sterility Assurance | Class II | Regenerative Processing Plant, LLC |
| 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 | Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ah... | Crystallization | Class II | VIONA PHARMACEUTICALS INC |
| Dec 10, 2024 | PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles,... | Lack of Sterility Assurance | Class II | Regenerative Processing Plant, LLC |
| 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 | 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, 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, 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 | 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 | Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per cart... | Failed Dissolution Specifications | Class II | AvKARE |
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.