Browse Drug Recalls

557 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 557 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 557 FDA drug recalls in 2024.

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DateProductReasonClassFirm
Sep 19, 2024 Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, M... Presence of Particulate Matter: Presence of glass particle. Class I Gilead Sciences, Inc.
Sep 18, 2024 Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sd... Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone ... Class I 123Herbals
Sep 18, 2024 EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz... CGMP deviations Class II EnviroServe Chemicals Inc.
Sep 17, 2024 Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distribu... Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with C... Class I Bionpharma Inc.
Sep 16, 2024 Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye... Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. Class II AbbVie Inc.
Sep 16, 2024 Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointm... Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. Class II AbbVie Inc.
Sep 11, 2024 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bot... Temperature abuse: Products exposed to improper temperature above drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Sep 11, 2024 Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Singl... cGMP Deviations: Temperature excursion Class II Mckesson Medical-Surgical Inc. Corporate Office
Sep 11, 2024 First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients:... Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes ... Class II Zhejiang Jingwei Pharmaceutical Co., Ltd.
Sep 5, 2024 Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose... Lack of Assurance of Sterility Class II Empower Pharmacy
Sep 3, 2024 Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc ... Microbial Contamination of Non-Sterile Product Class II Vivier Pharma, Inc.
Sep 3, 2024 Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets p... Failed Dissolution Specifications Class II Ascend Laboratories, LLC
Aug 30, 2024 Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmac... Subpotent Drug Class II Glenmark Pharmaceuticals Inc., USA
Aug 28, 2024 BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML... Microbial contamination of non-sterile Products - Class II PREQUEL SKIN
Aug 24, 2024 AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed b... Discoloration Class III Rubicon Research Private Limited
Aug 22, 2024 SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: P... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: P... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Com... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vi... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass ... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, C... Lack of Assurance of Sterility Class II ProRx LLC
Aug 21, 2024 Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufac... Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month lon... Class II Lupin Pharmaceuticals Inc.
Aug 20, 2024 Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g... LABELING: LABEL MIX-UP. Class III Elevate Oral Care
Aug 15, 2024 Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx o... Lack of Assurance of Sterility Class II Fagron Compounding Services
Aug 15, 2024 Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 sili... Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes pac... Class III Biocompatibles UK, Ltd.
Aug 12, 2024 Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (ND... Defective Container: patients are unable to get the solution out of the bottle as the spike of th... Class II FDC Limited
Aug 9, 2024 Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 80... Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-mo... Class II Direct Rx
Aug 8, 2024 Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bo... Failed Impurities/Degradation Specifications - at 18-month Stability testing Class II Preferred Pharmaceuticals, Inc.
Aug 8, 2024 Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Te... Superpotent Drug Class II Teva Pharmaceuticals USA, Inc
Aug 7, 2024 Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg ... Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related i... Class III Taro Pharmaceuticals U.S.A., Inc.
Aug 6, 2024 IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laborat... Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% ... Class II Dr. Reddy's Laboratories, Inc.
Aug 6, 2024 IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laborat... Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% ... Class II Dr. Reddy's Laboratories, Inc.
Aug 6, 2024 IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laborat... Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% ... Class II Dr. Reddy's Laboratories, Inc.
Aug 5, 2024 HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) ... CGMP Deviations: sterile water not used for production Class II Zeco LLC
Aug 5, 2024 Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a)... CGMP Deviations: sterile water not used for production Class II Zeco LLC
Aug 2, 2024 Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multipl... Lack of Assurance of Sterility Class II EMPOWER CLINIC SERVICES LLC
Aug 1, 2024 Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: ... Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg with... Class III Amneal Pharmaceuticals, LLC
Aug 1, 2024 Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1... Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. Class I Baxter Healthcare Corporation
Jul 31, 2024 Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by:... Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabap... Class II Granules Pharmaceuticals Inc.
Jul 31, 2024 Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count b... Failed Dissolution Specifications: below specification results Class II Glenmark Pharmaceuticals Inc., USA
Jul 26, 2024 Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose ... Presence of Particulate Matter: Complaint received of a glass particle in the vial. Class II Eugia US LLC
Jul 24, 2024 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Brau... Presence of Particulate Matter Class I B. Braun Medical Inc
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
Jul 22, 2024 Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmar... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Jul 18, 2024 Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in ... Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Dicl... Class I MAIN PRODUCTS INC
Jul 18, 2024 Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... Defective container; yellow colored spike from cap lodged in the nozzle Class II FDC Limited
Jul 18, 2024 Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid ... Label mix-up: Carton incorrectly labeled. Class III Granules Consumer Health Inc.
Jul 12, 2024 Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and ... Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared ... Class I Supercore Products Group Inc.
Jul 12, 2024 Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in ... Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared D... Class I SoloVital

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.