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 |
|---|---|---|---|---|
| Aug 27, 2025 | DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol ... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, Der... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bo... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g ... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 27, 2025 | Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (N... | CGMP Deviation; manufactured at the same facility where other products and lots were found to be ... | Class II | DermaRite Industries, LLC |
| Aug 20, 2025 | Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Pack... | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Aug 8, 2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, R... | CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Aug 7, 2025 | Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: G... | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current A... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 7, 2025 | Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462... | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current A... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 7, 2025 | Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by:... | CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current A... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 6, 2025 | Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured ... | CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable... | Class II | Westminster Pharmaceuticals LLC |
| Aug 6, 2025 | Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured... | CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable... | Class II | Westminster Pharmaceuticals LLC |
| Aug 6, 2025 | Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactur... | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 6, 2025 | Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured... | CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jul 30, 2025 | Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech... | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... | Class II | Cardinal Health Inc. |
| Jul 30, 2025 | Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South ... | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... | Class II | Cardinal Health Inc. |
| Jul 30, 2025 | RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Take... | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... | Class II | Cardinal Health Inc. |
| Jul 29, 2025 | Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by... | CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it canno... | Class II | Amerisource Health Services LLC |
| Jul 25, 2025 | Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactur... | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... | Class II | Alembic Pharmaceuticals Limited |
| Jul 25, 2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, R... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Jul 21, 2025 | Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per ca... | cGMP Deviations | Class II | YANGZHOU YULOU PAPER PRODUCTS CO., LTD |
| Jul 15, 2025 | Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only,... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Jul 11, 2025 | Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-00... | CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it canno... | Class II | Nostrum Laboratories, Inc. |
| Jul 10, 2025 | Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-... | CGMP Deviations | Class II | A.P. Deauville, LLC |
| Jul 10, 2025 | Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units... | CGMP Deviations; particulates identified during visual inspection | Class II | Pfizer Inc. |
| Jul 10, 2025 | Beauty & Skincare Power Stick original nourishing invisible protection roll-... | CGMP Deviations | Class II | A.P. Deauville, LLC |
| Jul 10, 2025 | Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units ... | CGMP Deviations; particulates identified during visual inspection | Class II | Pfizer Inc. |
| Jul 10, 2025 | Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder ... | CGMP Deviations | Class II | A.P. Deauville, LLC |
| Jul 9, 2025 | Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only,... | CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended ... | Class II | Ascend Laboratories, LLC |
| Jul 9, 2025 | Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only... | CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended ... | Class II | Ascend Laboratories, LLC |
| Jun 30, 2025 | Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, ... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc. |
| May 27, 2025 | Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: T... | CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. | Class II | Torrent Pharma Inc. |
| May 27, 2025 | Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured... | CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. | Class II | Torrent Pharma Inc. |
| May 22, 2025 | Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com ... | cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet dis... | Class II | Aurobindo Pharma USA Inc |
| May 15, 2025 | Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blist... | cGMP deviations | Class II | Amerisource Health Services LLC |
| May 9, 2025 | Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd.... | cGMP deviations | Class II | KVK Tech, Inc. |
| May 9, 2025 | Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only,... | cGMP deviations | Class II | KVK Tech, Inc. |
| Apr 28, 2025 | temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by:... | CGMP Deviations | Class II | Siddha Flower Essences, LLC. |
| Apr 24, 2025 | CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Fl... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulf... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - ... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE LIMITED |
| Apr 24, 2025 | Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%... | CGMP Deviations | Class II | KENIL HEALTHCARE PRIVATE 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.