Class II · Moderate risk
Aripiprazole Tablets
Out of specification (OOS) for Spectroscopic Identification test by IR.
FDA drug recalls in 2023
Every FDA drug recall initiated in 2023, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,122 recalls, newest first.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations
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