Class II · Moderate risk
Acetaminophen Tablets
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
FDA Drug Recalls
676 recalls · Class II, newest first
Class II · Moderate risk
Nicotinamide adenine dinucleotide
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide/Cyanocobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide/Cyanocobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Injections
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Injections
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Injections
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide/Cyanocobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide
Lack of Assurance of Sterility
Class II · Moderate risk
Nicotinamide adenine dinucleotide
Lack of Assurance of Sterility
Class II · Moderate risk
LX Bioboost Plus
Lack of Assurance of Sterility
Class II · Moderate risk
LL Bioboost Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
CJC-1295 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Indomethacin Extended-Release Capsules
cGMP deviations
Class II · Moderate risk
Theophylline
OOS results reported for the Dissolution (by UV) test.
Class II · Moderate risk
BD ChloraPrep Clear
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Class II · Moderate risk
Airsupra (albuterol and budesonide)
Defective delivery system
Class II · Moderate risk
Celecoxib Capsules
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Class II · Moderate risk
Chlorthalidone Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Celecoxib Capsules
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Class II · Moderate risk
Phentermine Hydrochloride Capsules
cGMP deviations