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
128 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.
Class II · Moderate risk
Adam's Polishes ALCOHOL BASED HAND SANITIZER
CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class I · High risk
Adam's Polishes ALCOHOL BASED HAND SANITIZER
Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.
Class II · Moderate risk
Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class I · High risk
Suave 24-Hour Protection Aerosol Antiperspirant Powder scent
Chemical contamination: presence of benzene
Class I · High risk
Sure Regular Antiperspirant Deodorant Aerosol
Chemical contamination: Presence of benzene
Class I · High risk
Sure Unscented Anti-perspirant Deodorant Aerosol
Chemical contamination: Presence of benzene
Class I · High risk
Brut Classic Antiperspirant & Deodorant
Chemical contamination: Presence of benzene
Class II · Moderate risk
Luxury 70% Isopropyl Alcohol
Labeling - product contains undeclared ethyl alcohol
Class II · Moderate risk
70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen
Labeling - product contains undeclared ethyl alcohol
Class I · High risk
ALPHA MALE+ Male Enhancer
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Class I · High risk
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+
Chemical Contamination: presence of benzene
Class I · High risk
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50
Chemical Contamination: presence of benzene
Class I · High risk
Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath)
Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.
Class II · Moderate risk
MEDICALLY MINDED Hand Sanitizer Gel
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.