Class II · Moderate risk
Shine & Clean Hand Sanitizer gel
CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.
FDA Drug Recalls
526 recalls, newest first
Class I · High risk
bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%
Chemical Contamination: Product contains methanol.
Class I · High risk
Mystic Shield PROTECTION
Chemical Contamination: Presence of Undeclared Methanol
Class II · Moderate risk
Saniderm ADVANCED HAND SANITIZER
CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
Class I · High risk
All Clean Hand Sanitizer
Chemical Contamination: Product contains undeclared methanol.
Class I · High risk
Saniderm ADVANCED HAND SANITIZER
Chemical Contamination: Product contains undeclared methanol.
Class II · Moderate risk
Walker Hand Sanitizer
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
Class II · Moderate risk
Walker Emulsions Hand Sanitizer
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
Class I · High risk
KORE ORGANIC CBD Oil Watermelon 15mg*
Chemical Contamination; product contains elevated levels of lead
Class I · High risk
Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary…
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction
Class III · Low risk
Proparacaine Hydrochloride Ophthalmic Solution
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Class III · Low risk
SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
SURE 48hr Confidence Nourishing Coconut invisible solid…
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class I · High risk
Silver Bullet
Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
Class I · High risk
Bow & Arrow
Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Class I · High risk
UP2, Dietary Supplement
Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Class I · High risk
Green Lumber Natural Fuel For Men capsule
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
Class I · High risk
Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Class III · Low risk
QUIK-CARE Aerosol Foam Hand Sanitizer
Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.
Class I · High risk
The Beast
Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis.
Class I · High risk
Titanium 4000
Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil.
Class I · High risk
Aphrodisiac Platinum 40000
Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil
Class I · High risk
Kopi Jantan Tradisional Natural Herbs Coffee
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.