Class II · Moderate risk
Dofetilide Capsules 500 mcg
CGMP Deviations: recalling drug products following an FDA inspection.
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
Dofetilide Capsules 250 mcg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Dofetilide Capsules
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Daptomycin for Injection 500 mg per vial
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Daptomycin for Injection 350 mg/vial
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Clopidogrel Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP 30 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP 15 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
BusPIRone Hydrochloride Tablets USP 7.5 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 80 mg* Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 40 mg* Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 20 mg* Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Class II · Moderate risk
Abelcet (Amphotericin B Lipid Complex)
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Class III · Low risk
Dermoplast FIRST AID ANTIBACTERIAL SPRAY
Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Class III · Low risk
Bd-102 Nf
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.