Browse Drug Recalls
378 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 378 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 378 FDA drug recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Dec 31, 2025 | CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count... | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... | Class II | Wizcure Pharmaa Private Limited |
| Dec 31, 2025 | Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief... | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... | Class II | Wizcure Pharmaa Private Limited |
| Dec 31, 2025 | Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drop... | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... | Class II | Wizcure Pharmaa Private Limited |
| Dec 31, 2025 | Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel... | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... | Class II | Wizcure Pharmaa Private Limited |
| Dec 31, 2025 | Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye D... | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... | Class II | Wizcure Pharmaa Private Limited |
| Dec 31, 2025 | Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manu... | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... | Class II | Wizcure Pharmaa Private Limited |
| Dec 31, 2025 | BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manuf... | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current g... | Class II | Wizcure Pharmaa Private Limited |
| Dec 19, 2025 | INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and ... | Failed Disintegration Specifications: above the time expected. | Class II | Sato Pharmaceutical Co., Ltd |
| Oct 10, 2025 | HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syr... | Lack of Assurance of Sterility. | Class II | Samsung Bioepis Co., Ltd. |
| Aug 22, 2025 | Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide... | Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF res... | Class II | GRACE & FIRE PTY LTD |
| Aug 22, 2025 | Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Min... | Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF res... | Class II | GRACE & FIRE PTY LTD |
| 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 |
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.