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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Apr 1, 2026 | fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (... | cGMP deviations. | Class II | Wells Pharma of Houston LLC |
| Apr 1, 2026 | Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1... | cGMP deviations. | Class II | Wells Pharma of Houston LLC |
| Mar 27, 2026 | Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufac... | cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im... | Class II | Appco Pharma LLC |
| Mar 27, 2026 | Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufa... | cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im... | Class II | Appco Pharma LLC |
| Mar 27, 2026 | Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufac... | cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im... | Class II | Appco Pharma LLC |
| Mar 20, 2026 | Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by... | CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. | Class II | Leading Pharma, LLC |
| Mar 19, 2026 | Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Syste... | CGMP Deviations: use of an unapproved raw material | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 19, 2026 | Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Syste... | CGMP Deviations: use of an unapproved raw material | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 19, 2026 | Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Syste... | CGMP Deviations: use of an unapproved raw material | Class II | Teva Pharmaceuticals USA, Inc |
| Mar 16, 2026 | Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit | Class II | Cipla USA, Inc. |
| Mar 16, 2026 | Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit | Class II | Cipla USA, Inc. |
| Mar 16, 2026 | Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manu... | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit | Class II | Cipla USA, Inc. |
| Feb 13, 2026 | Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01... | CGMP Deviations This recall has been initiated due to failing to complete process validation and ... | Class II | Harbin Jixianglong Biotech Co., Ltd. |
| Feb 13, 2026 | Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-0... | CGMP Deviations This recall has been initiated due to failing to complete process validation and ... | Class II | Harbin Jixianglong Biotech Co., Ltd. |
| Feb 2, 2026 | Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4... | cGMP deviations | Class II | Pro Numb Tattoo Numbing Spray LLC |
| Feb 2, 2026 | Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL]... | cGMP deviations | Class II | Pro Numb Tattoo Numbing Spray LLC |
| Jan 21, 2026 | Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100... | cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. | Class II | Unichem Pharmaceuticals USA Inc. |
| Jan 20, 2026 | Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium C... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | 1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sa... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, M... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box,... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
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.