Browse Drug Recalls

3,430 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,430 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 3,430 FDA drug recalls.

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DateProductReasonClassFirm
Aug 5, 2026 Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufac... CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. Class II Zydus Pharmaceuticals (USA) Inc
Jul 23, 2026 Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distribu... CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described... Class II Glenmark Pharmaceuticals Inc., USA
Jun 29, 2026 Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactur... cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Class II Cipla USA, Inc.
Jun 29, 2026 Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactur... cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Class II Cipla USA, Inc.
Jun 29, 2026 Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactur... cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Class II Cipla USA, Inc.
Jun 23, 2026 Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg p... CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long... Class II Lupin Pharmaceuticals Inc.
Jun 22, 2026 DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Direct Rx
Jun 12, 2026 Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-relea... CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed... Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Jun 4, 2026 Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed b... CGMP Deviations Class II Amgen, Inc.
Jun 4, 2026 Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed b... CGMP Deviations Class II Amgen, Inc.
Jun 4, 2026 Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed b... CGMP Deviations Class II Amgen, Inc.
Jun 4, 2026 Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc.
Jun 4, 2026 Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (N... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc.
Jun 2, 2026 Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin S... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Su... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufacture... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neom... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactur... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured f... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case,... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 u... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 uni... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neo... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
Jun 2, 2026 Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured ... CGMP Deviations; deficiencies observed during FDA inspection Class II Dabur India Limited
May 28, 2026 Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Aja... CGMP Deviations Class II Ajanta Pharma USA Inc
May 19, 2026 Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net ... cGMP deviations Class II Shimoga Chemicals
May 14, 2026 Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem ... CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-dulox... Class II Asclemed USA Inc.
Apr 29, 2026 Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactur... CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable in... Class II Zydus Pharmaceuticals (USA) Inc
Apr 29, 2026 Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactur... CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable in... Class II Zydus Pharmaceuticals (USA) Inc
Apr 29, 2026 Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by... CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 pp... Class II Ajanta Pharma Ltd.
Apr 29, 2026 Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by... CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 pp... Class II Ajanta Pharma Ltd.
Apr 29, 2026 Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 2724... CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 pp... Class II Ajanta Pharma Ltd.
Apr 23, 2026 iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made... Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by th... Class II Thea Pharma, Inc.
Apr 23, 2026 Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (1... Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by th... Class II Thea Pharma, Inc.
Apr 21, 2026 Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr... CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Class II Breckenridge Pharmaceutical, Inc.
Apr 8, 2026 TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Ma... CGMP Deviations; the firm discontinued required stability testing for products on the market stil... Class II Blaine Labs Inc
Apr 8, 2026 TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 ... CGMP Deviations: product manufactured in the same facility under the same conditions as the produ... Class II Blaine Labs Inc
Apr 8, 2026 vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manuf... CGMP Deviations; the firm discontinued required stability testing for products on the market stil... Class II Blaine Labs Inc
Apr 8, 2026 Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) ... CGMP Deviations; product manufactured in the same facility under the same conditions as the produ... Class II Blaine Labs Inc
Apr 8, 2026 TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL)... CGMP Deviations; the firm discontinued required stability testing for products on the market stil... Class II Blaine Labs Inc
Apr 8, 2026 Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains,... CGMP Deviations; the firm discontinued required stability testing for products on the market stil... Class II Blaine Labs Inc
Apr 8, 2026 TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 F... CGMP Deviations; the firm discontinued required stability testing for products on the market stil... Class II Blaine Labs Inc
Apr 1, 2026 fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 ... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells phar... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg pe... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg ... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500... cGMP deviations. Class II Wells Pharma of Houston 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.