Class II · Moderate risk
Fentanyl 500mcg
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Tacrolimus Capsules
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Class II · Moderate risk
rOPINIRole Tablets USP 5 mg* 100-count bottle
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 4 mg* 100-count bottle
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 3 mg*
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 2 mg*
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 1 mg*
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 0.5 mg*
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
rOPINIRole Tablets USP 0.25 mg*
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pravastatin Sodium Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pravastatin Sodium Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pravastatin Sodium Tablets USP 20 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pravastatin Sodium Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pirfenidone Tablets 801 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Vigabatrin for Oral Solution
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tadalafil Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Succinylcholine Chloride Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets USP 80 mg Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets USP 40 mg Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets USP 20 mg Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets
CGMP Deviations: recalling drug products following an FDA inspection.