Browse Drug Recalls
557 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 557 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 557 FDA drug recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 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 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 | Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, ... | Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules | Class I | Astellas Pharma US 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 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 | Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Produc... | Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules | Class I | Astellas Pharma US 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 20, 2024 | Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg... | Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved dr... | Class I | ENDO USA, 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 19, 2024 | Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, ... | Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configur... | Class III | West-Ward Columbus Inc |
| Dec 18, 2024 | Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops,... | LABELING: LABEL MIX-UP | Class III | AvKARE |
| Dec 18, 2024 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only... | CGMP Deviations | Class II | Eugia US LLC |
| Dec 18, 2024 | Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufa... | Non-Sterility | Class I | Alcon Research LLC |
| Dec 18, 2024 | Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant... | LABELING: LABEL MIX-UP | Class III | AvKARE |
| 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 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 | Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufact... | Failed Impurities/Degradation Specifications | Class III | SOMERSET THERAPEUTICS LLC |
| Dec 16, 2024 | FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Di... | Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with und... | Class I | SHOPPERS- PLAZA |
| 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 | FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO AL... | Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofen... | Class I | GNMart LLC |
| Dec 12, 2024 | Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, M... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Dec 12, 2024 | Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, In... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Dec 12, 2024 | Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufacture... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Dec 12, 2024 | Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma,... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| 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 12, 2024 | Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured... | Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undecla... | Class I | Buy-Herbal |
| Dec 12, 2024 | Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactur... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Dec 12, 2024 | Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactur... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| Dec 12, 2024 | Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufact... | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Class III | Akron Pharma, Inc. |
| 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 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 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 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 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 |
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.