Class I · High risk
Samurai-X Honey 6800
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I drug recalls - the high-risk category
Class I is the FDA's most serious recall category: a reasonable probability that using the product will cause serious health consequences or death. It is a small share of all recalls, but the one to check first if a medication you take appears here.
1,750 recalls, newest first.
Class I · High risk
Flower Power
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Weiner Boner Honey
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Spanish Fly 22K capsules
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Treprostinil Injection
Presence of Particulate Matter.
Class I · High risk
Methocarbamol Injection
Presence of Particulate Matter
Class I · High risk
ForeverMen Natural Energy Boost Capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
Class I · High risk
Arize Herbal Dietary Supplement
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
SCHWINNNG Herbal Dietary Supplement
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
Sustain Herbal Dietary Supplement
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
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
To the Moon Capsules
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class I · High risk
Ram It
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class I · High risk
TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid
Chemical Contamination; presence of benzene.
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
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
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
Zenzedi (Dextroamphetamine Sulfate)
Labeling: Label Mix-up
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