Class II · Moderate risk
Maximum Zone2 Topical Analgesic
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
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
New & Improved Blue Gel Anesthetic
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Class II · Moderate risk
Fentanyl 500mcg
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
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.