Browse Drug Recalls

3,458 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,458 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 3,458 FDA drug recalls.

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DateProductReasonClassFirm
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
Apr 24, 2025 Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Min... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Min... 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 Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesi... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint... CGMP Deviations Class II KENIL HEALTHCARE PRIVATE LIMITED
Apr 24, 2025 Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Min... 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.