Class I · High risk
Lotrimin Af
Chemical Contamination: presence of benzene
FDA Drug Recalls
124 recalls · Class I, newest first
Class I · High risk
Lotrimin Af
Chemical Contamination: presence of benzene
Class I · High risk
Lotrimin Af
Chemical Contamination: presence of benzene
Class I · High risk
Coppertone SPORT Sunscreen Spray 50
Chemical contamination; presence of benzene
Class I · High risk
Coppertone SPORT MINERAL 50 Sunscreen Spray
Chemical contamination; presence of benzene
Class I · High risk
Coppertone Pure & Simple baby 50 Sunscreen Spray
Chemical contamination; presence of benzene
Class I · High risk
Coppertone Pure & Simple kids 50 Sunscreen Spray
Chemical contamination; presence of benzene
Class I · High risk
Coppertone Pure & Simple 50 Sunscreen Spray
Chemical contamination; presence of benzene
Class I · High risk
Glucagon Emergency Kit for Low Blood Sugar
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Class I · High risk
Ruzurgi (amifampridine)
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
Class I · High risk
AMINOSYN II 15% An Amino Acid Injection
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Class I · High risk
Avicel RC-591 NF
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Class I · High risk
Firvanq (vancomycin hydrochloride for oral solution)
Product Mix-up: Incorrect diluent component included in the kit.
Class I · High risk
X Rated Honey for Men
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Class I · High risk
Hydro Pinapple Burn Max Health Thach Dua
Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
Class I · High risk
Sodium Bicarbonate in 5% Dextrose Injection
Non-Sterility: firm's third party lab confirmed microbial contamination.
Class I · High risk
Lidocaine Hydrochloride Topical Solution
Superpotent Drug
Class I · High risk
365 SKINNY High Intensity Capsules
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.
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
Atovaquone Oral Suspension
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class I · High risk
Limar Hand Sanitizer
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Class I · High risk
Prairie Wolf Distillery Alcohol Antiseptic 80%
Hand sanitizer packaged in bottles that resemble beverage containers.