Browse Drug Recalls
415 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 415 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 415 FDA drug recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 22, 2025 | BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chlori... | Lack of Assurance of Sterility. | Class II | Taizhou Kangping Medical Science And Technology... |
| 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 |
| Jun 11, 2025 | Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for:... | Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle. | Class III | Macleods Pharmaceuticals Ltd |
| May 7, 2025 | Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufac... | Failed Impurities/Degradation Specifications | Class II | Alembic Pharmaceuticals Limited |
| May 6, 2025 | ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA... | Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and... | Class I | EnShiShiXiangNiShangMaoYouXianGongSi |
| 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 |
| 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 18, 2025 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only... | Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lod... | Class II | FDC Limited |
| Apr 9, 2025 | Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes,... | CGMP Deviations | Class II | Apipharma |
| Apr 9, 2025 | Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g... | CGMP Deviations | Class II | Apipharma |
| Mar 21, 2025 | Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manu... | Lack of Assurance of Sterility: Media fill with bacterial contamination | Class II | Somerset Therapeutics Private Limited |
| Mar 21, 2025 | Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manuf... | Lack of Assurance of Sterility: Media fill with bacterial contamination | Class II | Somerset Therapeutics Private Limited |
| Mar 21, 2025 | Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Ma... | Lack of Assurance of Sterility: Media fill with bacterial contamination | Class II | Somerset Therapeutics Private Limited |
| Mar 21, 2025 | Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Via... | Lack of Assurance of Sterility: Media fill with bacterial contamination | Class II | Somerset Therapeutics Private Limited |
| Mar 21, 2025 | Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manuf... | Lack of Assurance of Sterility: Media fill with bacterial contamination | Class II | Somerset Therapeutics Private Limited |
| Mar 11, 2025 | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles,... | Defective container: Unable to get the solution out of the bottle as the spike of the cap was lod... | Class II | FDC Limited |
| Feb 12, 2025 | ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Steri... | Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. | Class II | Wuxi Medical lnstrument Factory Co., Ltd. |
| Oct 29, 2024 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... | Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lod... | Class II | FDC Limited |
| Jul 23, 2024 | Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 1... | Defective container: unable to get the solution out of the bottle as the spike of the cap was lod... | Class II | FDC Limited |
| Apr 26, 2024 | traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distri... | Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count t... | Class II | Rubicon Research Private Limited |
| Apr 25, 2024 | Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (N... | Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several co... | Class II | FDC Limited |
| Apr 9, 2024 | Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only,... | Cross Contamination with Other Products | Class III | Second Tokushima Factory, Otsuka Pharmaceutical... |
| Apr 9, 2024 | Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 5... | Cross Contamination with Other Products | Class III | Second Tokushima Factory, Otsuka Pharmaceutical... |
| Apr 9, 2024 | Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, ... | Cross Contamination with Other Products | Class III | Second Tokushima Factory, Otsuka Pharmaceutical... |
| Apr 9, 2024 | Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only,... | Cross Contamination with Other Products | Class III | Second Tokushima Factory, Otsuka Pharmaceutical... |
| Mar 27, 2024 | Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treat... | CGMP Deviations | Class II | NATCO Pharma Limited |
| Mar 23, 2024 | Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle,... | Chemical Contamination: Product manufactured with ethanol API that contains methanol | Class I | Aruba Aloe Balm N.V. |
| Mar 23, 2024 | Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in... | Chemical Contamination: Product manufactured with ethanol API that contains methanol | Class I | Aruba Aloe Balm N.V. |
| Feb 12, 2024 | Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs... | CGMP Deviations: Out of specification for residual solvents. | Class II | Micro Labs Limited |
| Feb 9, 2024 | Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured b... | Failed Stability Specifications: Out of specification for blend uniformity. | Class II | Micro Labs Limited |
| Jan 10, 2024 | Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for I... | Lack of Sterility Assurance: Aseptic process simulation failure. | Class II | BE PHARMACEUTICALS AG |
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.