Class I · High risk
suntegrity
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
FDA Drug Recalls
231 recalls · Class I, newest first
Class I · High risk
Tirzepatide 10 mg/0.5 mL Sterile Solution
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Class I · High risk
Sapropterin Dihydrochloride Powder for Oral Solution 100mg
Sub-potent Drug; powder discoloration associated with decreased potency
Class I · High risk
Javygtor (sapropterin dihydrochloride)
Sub-potent Drug; powder discoloration associated with decreased potency
Class I · High risk
Aruba Aloe Hand Sanitizer Gel
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Class I · High risk
Alcoholada Gel
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Class I · High risk
Honey Manuka Bunny Love
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Alphastrip Male Performance Enhancer
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
The GOAT SUBLINGUAL STRIP
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Silverback Xxx Power Male Enhancement
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
libigrow RED DRAGON+
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
GoHARD 25000
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Pink Pussycat Honey
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
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 · 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
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
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
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.