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 |
|---|---|---|---|---|
| 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. |
| 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 14, 2024 | Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml... | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... | Class II | Keystone Industries |
| Nov 14, 2024 | Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 m... | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... | Class II | Keystone Industries |
| Nov 14, 2024 | Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, M... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit | Class II | Amerisource Health Services LLC |
| 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 |
| Nov 14, 2024 | Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada. | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... | Class II | Keystone Industries |
| Nov 14, 2024 | M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 ... | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... | Class II | Keystone Industries |
| Nov 14, 2024 | Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use... | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... | Class II | Keystone Industries |
| Nov 14, 2024 | Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Glut... | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... | Class II | Keystone Industries |
| Nov 14, 2024 | Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29... | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... | Class II | Keystone Industries |
| Nov 14, 2024 | Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister ... | CGMP Deviations: Released product should have been rejected. | Class II | LNK International, Inc. |
| Nov 14, 2024 | Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 m... | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... | Class II | Keystone Industries |
| Nov 14, 2024 | safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 o... | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... | Class II | Keystone Industries |
| Nov 14, 2024 | Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit | Class II | Amerisource Health Services LLC |
| Nov 14, 2024 | Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net C... | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... | Class II | Keystone Industries |
| Nov 14, 2024 | Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (2... | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... | Class II | Keystone Industries |
| Nov 14, 2024 | Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle,... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit | Class II | Amerisource Health Services LLC |
| Nov 14, 2024 | Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manu... | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... | Class II | Keystone Industries |
| Nov 13, 2024 | Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By:... | CGMP Deviations: lack of adequate release testing. | Class II | Brands International Corporation |
| Nov 11, 2024 | Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, ... | cGMP Deviations: Observations were made that some blister card-foils were separating from the bli... | Class II | Safecor Health, LLC |
| Nov 11, 2024 | Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box,... | cGMP Deviations: Observations were made that some blister card-foils were separating from the bli... | Class II | Safecor Health, LLC |
| Nov 11, 2024 | Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose ... | cGMP Deviations: Observations were made that some blister card-foils were separating from the bli... | Class II | Safecor Health, LLC |
| Nov 11, 2024 | Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count ... | cGMP Deviations: Observations were made that some blister card-foils were separating from the bli... | Class II | Safecor Health, LLC |
| Nov 11, 2024 | Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit... | cGMP Deviations: Observations were made that some blister card-foils were separating from the bli... | Class II | Safecor Health, LLC |
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.