Class I · High risk
Goose Creek Hand Sanitizer aloe Grape Soda
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
FDA Drug Recalls
124 recalls · Class I, newest first
Class I · High risk
Goose Creek Hand Sanitizer aloe Beach Dreams
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I · High risk
Goose Creek Hand Sanitizer aloe Limoncello
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I · High risk
Goose Creek Hand Sanitizer aloe Blueberry Limeade
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I · High risk
SS Tangerine & Guava Scented Sanitizer
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I · High risk
SS Lemon Zest Scented Sanitizer
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I · High risk
SS Lavender & Herbs Scented Sanitizer
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I · High risk
SS Eucalyptus Mint Scented Sanitizer
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I · High risk
SS Coconut Breeze Scented Sanitizer
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I · High risk
Ulta beauty Fresh Lemon Citron Frais
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Class I · High risk
BD ChloraPrep Hi-Lite Orange 26 mL Applicator
Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
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
Thumbs up 7 Red 70K capsules
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Class I · High risk
Shogun-X capsules
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Class I · High risk
Krazy Night capsule
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
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
Lite'n Foamy Lemon Blossom Hand Sanitizer
Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans
Class I · High risk
Xultophy 100/3.6
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class I · High risk
TRESIBA FlexTouch
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class I · High risk
TRESIBA (insulin degludec injection)
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class I · High risk
TRESIBA FlexTouch
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.