Class I · High risk
Thyroid Tablets
Superpotent Drug
FDA Drug Recalls
28 recalls · Class I, newest first
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Class I · High risk
0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
Class I · High risk
Lactated Ringer's Injection USP
Presence of Particulate matter.
Class I · High risk
Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Class I · High risk
Tyenne (tocilizumab-aazg)
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Class I · High risk
Glutathione 200 mg/mL
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Class I · High risk
Morphine Sulfate Injection
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Class I · High risk
Optiray Imaging Bulk Package-350
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Class I · High risk
Papaverine HCl Injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Class I · High risk
Cefazolin in Dextrose
Presence of Particulate Matter
Class I · High risk
Cyclophosphamide for Injection
Presence of Particulate Matter; identified as stainless steel
Class I · High risk
Cyclophosphamide for Injection
Presence of Particulate Matter; identified as stainless steel
Class I · High risk
Glutathione
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Class I · High risk
Cetirizine Hydrochloride Tablets USP 5 mg
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Class I · High risk
Gas-X Extra Strength
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Class I · High risk
BEEKEEPER'S NATURALS Saline Nasal Spray
Microbial Contamination of Non-Sterile Products
Class I · High risk
BD ChloraPrep FREPP Clear
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Class I · High risk
BD ChloraPrep Clear
Non-Sterility: Due to presence of Aspergillus penicillioides.
Class I · High risk
DOXOrubin Hydrochloride Liposome injection
Presence of Particulate matter: Particulate matter identified as glass.
Class I · High risk
Lactated Ringer's Injection USP
Presence of Particulate Matter.
Class I · High risk
MG217 Multi-Symptom Treatment Cream & Skin Protectant
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Class I · High risk
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Class I · High risk
Kian Pee Wan Capsules
Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.