Class II · Moderate risk
Triple SupremeZen Gold 3500
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
FDA Drug Recalls
921 recalls · Class II, newest first
Class II · Moderate risk
PremierZen Platinum 5000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk
Lite'n Foamy Healthcare Personnel Handwash
CGMP Deviations
Class II · Moderate risk
Lite'n Foamy Eucalyptus Mint Sanitizing Handwash
CGMP Deviations
Class II · Moderate risk
Lite'n Foamy E2 Sanitizing Handwash
CGMP Deviations
Class II · Moderate risk
Antiseptic Hand Cleaner
CGMP Deviations
Class II · Moderate risk
foamyiQ Lemon Blossom Hand Sanitizer
CGMP Deviations
Class II · Moderate risk
Thumbs Up 7 Red 70K
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
Class II · Moderate risk
Cefprozil for Oral Suspension USP
Superpotent Drug
Class II · Moderate risk
Imperial Extreme 2000 Capsules
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class II · Moderate risk
PremierZen Black 5000 capsules
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class II · Moderate risk
Mometasone Furoate Topical Solution
CGMP Deviaitons
Class II · Moderate risk
Thumbs Up 7 Blue 69K
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
Class II · Moderate risk
ViCTOZA (liraglutide)
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
Saxenda (liraglutide)
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
OZEMPIC (semaglutide)
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
ChloraPrep With Tint 2% w/v chlorhexidine gluconate
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
ChloraPrep One-Step 2% w/v chlorhexidine gluconate
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
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate
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
BD ChloraPrep Clear
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
Neomycin Sulfate Tablets
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Class II · Moderate risk
Omeprazole Delayed Release Capsules
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Brompheniramine Maleate
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
CYANOCOBAL Injection 1000MCG/ML 25X1ML
CGMP Deviations: Intermittent exposure to temperature excursion during storage.