Class I · High risk
Lidocaine Hydrochloride
Superpotent Drug
FDA Drug Recalls
18 recalls · Class I, newest first
Class I · High risk
Lidocaine Hydrochloride Topical Solution
Superpotent Drug
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 I · High risk
Limar Hand Sanitizer
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Class I · High risk
MEDICALLY MINDED Hand Sanitizer Gel
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
MEDICALLY MINDED Hand Sanitizer Gel
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
Ginseng Power 5000 capsule
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Class I · High risk
Premium OrgaZEN 7000 capsule
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Class I · High risk
69MODE Blue 69 capsule
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
Thumbs Up 7 White 11K capsule
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
Thumbs Up 7 Black 25K capsule
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
Shogun-X 7000 capsule
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
Enoxaparin Sodium Injection
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)
Class I · High risk
Enoxaparin Sodium Injection
Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
Class I · High risk
Spironolactone Tablets
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.