Class II · Moderate risk Terminated
Thumbs Up 7 Red 70K
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Cefprozil for Oral Suspension USP
Reason Superpotent Drug
Class II · Moderate risk Terminated
PremierZen Black 5000 capsules
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class II · Moderate risk Terminated
Mometasone Furoate Topical Solution
Reason CGMP Deviaitons
Class III · Low risk Terminated
Metformin HCl Extended-Release Tablets
Reason Failed Moisture Limits: Out of specification for water content
Class II · Moderate risk Terminated
Thumbs Up 7 Blue 69K
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
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 II · Moderate risk Terminated
ViCTOZA
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 II · Moderate risk Terminated
Saxenda
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 II · Moderate risk Terminated
Ozempic
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 III · Low risk Terminated
Candesartan Cilexetil Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
ChloraPrep With Tint 2% w/v chlorhexidine gluconate
Reason CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class II · Moderate risk Terminated
ChloraPrep One-Step 2% w/v chlorhexidine gluconate
Reason CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class II · Moderate risk Terminated
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate
Reason Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class II · Moderate risk Terminated
BD ChloraPrep Clear
Reason Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
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.