Browse Drug Recalls
3,394 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,394 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 3,394 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 |
| Jan 20, 2026 | Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per c... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towele... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Cu... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 pa... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wi... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme Unit... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette,... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, M... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wi... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.1... | CGMP Deviations | Class II | ACME UNITED CORPORATION |
| Jan 20, 2026 | First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, b... | 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.