Class I · High risk Ongoing
Purely Soothing 15% MSM Drops
Reason Non-Sterility
FDA Drug Recalls
220 recalls · Class I, newest first
Class I · High risk Ongoing
Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand…
Reason Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
Class I · High risk Ongoing
Delsam Pharma's ARTIFICIAL TEARS
Reason Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class I · High risk Ongoing
Artificial Tears
Reason Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Class I · High risk Ongoing
Adam's Polishes ALCOHOL BASED HAND SANITIZER
Reason Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.
Class I · High risk Ongoing
Suave 24-Hour Protection Aerosol Antiperspirant Powder scent
Reason Chemical contamination: presence of benzene
Class I · High risk Ongoing
Sure Regular Antiperspirant Deodorant Aerosol
Reason Chemical contamination: Presence of benzene
Class I · High risk Ongoing
Sure Unscented Anti-perspirant Deodorant Aerosol
Reason Chemical contamination: Presence of benzene
Class I · High risk Ongoing
Brut Classic Antiperspirant & Deodorant
Reason Chemical contamination: Presence of benzene
Class I · High risk Ongoing
Lidocaine Hydrochloride
Reason Superpotent Drug
Class I · High risk Ongoing
Lidocaine Hydrochloride Topical Solution
Reason Superpotent Drug
Class I · High risk Ongoing
ALPHA MALE+ Male Enhancer
Reason Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Class I · High risk Ongoing
Neutrogena Beach Defense water+sun protection sunscreen spray…
Reason Chemical Contamination: presence of benzene
Class I · High risk Ongoing
Neutrogena Beach Defense water+sun protection sunscreen spray…
Reason Chemical Contamination: presence of benzene
Class I · High risk Ongoing
Vy&Tea
Reason Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.
Class I · High risk Ongoing
Limar Hand Sanitizer
Reason Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Class I · High risk Ongoing
MEDICALLY MINDED Hand Sanitizer Gel
Reason Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
Class I · High risk Ongoing
MEDICALLY MINDED Hand Sanitizer Gel
Reason Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.
Class I · High risk Ongoing
Ginseng Power 5000 capsule
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Class I · High risk Ongoing
Premium OrgaZEN 7000 capsule
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Class I · High risk Ongoing
69MODE Blue 69 capsule
Reason Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making it an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.
Class I · High risk Ongoing
Thumbs Up 7 White 11K capsule
Reason Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil sildenafil, and vardenafil, FDA approved drugs making them an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.
Class I · High risk Ongoing
Thumbs Up 7 Black 25K capsule
Reason Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil, an FDA approved drug making this an unapproved drug for which the safety and efficacy has not been established and therefore subject to recall.
Class I · High risk Ongoing
Shogun-X 7000 capsule
Reason Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Class I · High risk Ongoing
Enoxaparin Sodium Injection
Reason Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)