1,739 recalls · Class I, newest first
Reason Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Reason Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Reason Chemical Contamination; presence of benzene.
Reason Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Reason Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Reason Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Reason Labeling: Label Mix-up
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Reason Microbial Contamination of Non-Sterile Products
Reason Microbial Contamination of Non-Sterile Products
Reason Presence of particulate matter: glass
Reason Chemical Contamination: presence of benzene
Reason Presence of Particulate Matter; identified as glass
Reason Presence of Particulate Matter; identified as glass
Reason Presence of Particulate Matter; identified as glass
Reason Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
Reason Chemical Contamination; presence of benzene.
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Reason Defective Container: powder may leak out of the pouch
Reason Non-Sterility