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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.