Class I · High risk Ongoing
GoHARD 25000
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
FDA Drug Recalls
220 recalls · Class I, newest first
Class I · High risk Ongoing
Pink Pussycat Honey
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Samurai-X Honey 6800
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Flower Power
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Weiner Boner Honey
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Spanish Fly 22K capsules
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Treprostinil Injection
Reason Presence of Particulate Matter.
Class I · High risk Ongoing
Methocarbamol Injection
Reason Presence of Particulate Matter
Class I · High risk Ongoing
Arize Herbal Dietary Supplement
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Class I · High risk Ongoing
SCHWINNNG Herbal Dietary Supplement
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Class I · High risk Ongoing
Sustain Herbal Dietary Supplement
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.
Class I · High risk Ongoing
To the Moon Capsules
Reason Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class I · High risk Ongoing
Ram It
Reason Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class I · High risk Ongoing
Neptune's Fix
Reason 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 Ongoing
Neptune's Fix
Reason 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 Ongoing
Neptune's Fix
Reason 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 Ongoing
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag
Reason 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 Ongoing
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag
Reason 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 Ongoing
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride
Reason 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 Ongoing
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride
Reason 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 Ongoing
FentaNYL citrate PF
Reason 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 Ongoing
FentaNYL citrate PF
Reason 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 Ongoing
Robitussin Honey CF Max Nighttime Adult
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Ongoing
Robitussin Honey CF Max Non-Drowsy Adult
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Ongoing
Bleomycin for Injection
Reason Presence of particulate matter: glass