Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Glimepiride Tablets
CGMP Deviations
Class II · Moderate risk
Glimepiride Tablets
CGMP Deviations
Class II · Moderate risk
Doxazosin Tablets
CGMP Deviations
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP
CGMP Deviations
Class II · Moderate risk
Atorvastatin Calcium Tablets
CGMP Deviations
Class II · Moderate risk
Verapamil Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Class III · Low risk
Epinephrine Professional EMS
Labeling; Incorrect NDC number on outer carton of product.
Class II · Moderate risk
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class II · Moderate risk
Dianeal Low Calcium
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class II · Moderate risk
Dabigatran Etexilate 150mg Capsules
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Class II · Moderate risk
Dabigatran Etexilate Capsules
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Class II · Moderate risk
Pantoprazole Sodium Delayed Release Tablets USP 40mg
CGMP Deviations: Discoloration
Class I · High risk
Atovaquone Oral Suspension USP
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Class II · Moderate risk
Simvastatin
cGMP deviations
Class II · Moderate risk
Simvastatin
cGMP deviations
Class II · Moderate risk
Simvastatin
cGMP deviations
Class II · Moderate risk
Simvastatin
cGMP deviations
Class II · Moderate risk
Glimepiride
cGMP deviations
Class II · Moderate risk
Glimepiride
cGMP deviations
Class II · Moderate risk
Glimepiride
cGMP deviations
Class II · Moderate risk
Ropinirole
cGMP deviations
Class II · Moderate risk
Ropinirole
cGMP deviations
Class II · Moderate risk
Finasteride
cGMP deviations
Class II · Moderate risk
Montelukast Sodium Tablets
cGMP deviations