Class I · High risk
Neptune's Fix
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
FDA Drug Recalls
231 recalls · Class I, newest first
Class I · High risk
Neptune's Fix
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I · High risk
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk
FentaNYL citrate PF
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk
FentaNYL citrate PF
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk
Robitussin Honey CF Max Nighttime Adult
Microbial Contamination of Non-Sterile Products
Class I · High risk
Robitussin Honey CF Max Non-Drowsy Adult
Microbial Contamination of Non-Sterile Products
Class I · High risk
Bleomycin for Injection
Presence of particulate matter: glass
Class I · High risk
Atropine Sulfate Injection
Presence of Particulate Matter; identified as glass
Class I · High risk
8.4 % Sodium Bicarbonate Injection
Presence of Particulate Matter; identified as glass
Class I · High risk
4.2% Sodium Bicarbonate Injection
Presence of Particulate Matter; identified as glass
Class I · High risk
Magnum XXL 9800
Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Class I · High risk
Up&Up brand dry eye relief
Non-Sterility
Class I · High risk
Rugby brand Lubricating Tears Eye Drops
Non-Sterility
Class I · High risk
Lubricant Eye Drops
Non-Sterility
Class I · High risk
Multi-action Relief Drops
Non-Sterility
Class I · High risk
Lubricant Gel Drops
Non-Sterility
Class I · High risk
Lubricant Gel Drops
Non-Sterility
Class I · High risk
CVS Health brand Mild Moderate Lubricating Eye Drops
Non-Sterility
Class I · High risk
Lubricant Eye Drops
Non-Sterility
Class I · High risk
EQUATE brand Hydration PF Lubricant Eye Drops
Non-Sterility