Class I · High risk Terminated
Ulta beauty Fresh Lemon Citron Frais
Reason Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
BD ChloraPrep Hi-Lite Orange 26 mL Applicator
Reason 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 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 Terminated
Thumbs up 7 Red 70K capsules
Reason 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 Terminated
Shogun-X capsules
Reason 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 Terminated
Krazy Night capsule
Reason 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 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 Terminated
Lite'n Foamy Lemon Blossom Hand Sanitizer
Reason Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans
Class I · High risk Terminated
Xultophy 100/3.6
Reason 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 Terminated
TRESIBA FlexTouch
Reason 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 Terminated
Tresiba
Reason 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 Terminated
TRESIBA FlexTouch
Reason 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 Terminated
NovoLog
Reason 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 Terminated
NovoLog FlexPen
Reason 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 Terminated
Levemir FlexTouch
Reason 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 Terminated
Fiasp
Reason 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 Terminated
Fiasp PenFill
Reason 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 Terminated
Fiasp FlexTouch
Reason 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 Terminated
ChloraPrep With Tint 2% w/v chlorhexidine gluconate
Reason Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Class I · High risk Terminated
ChloraPrep One-Step 2% w/v chlorhexidine gluconate
Reason Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Class I · High risk Terminated
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate
Reason Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.