Class I · High risk
Magnum XXL 9800
Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
FDA Drug Recalls
11 recalls, newest first
Class I · High risk
Dr. Ergin's SugarMD
MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
Class I · High risk
Kuka Flex Forte caplets
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class I · High risk
Reumo Flex caplets
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class I · High risk
Artri King Reforzado con Origa y Omega 3 tablets
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class I · High risk
The Rock
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
Vegetal Vigra
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
DYNAMITE SUPER capsule
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
NUX Male Enhancement capsule
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
Pro Power Knight Plus capsule
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand…
Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.