Class II · Moderate risk Terminated
Allergy Relief
Reason Failed Impurities/Degradation Specifications
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Allergy Relief
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Non-Drowsy Allergy Relief
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Allergy
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Maximum Zone2 Topical Analgesic
Reason cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Class II · Moderate risk Terminated
New & Improved Blue Gel Anesthetic
Reason cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Class II · Moderate risk Ongoing
Fentanyl 500mcg
Reason Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Class II · Moderate risk Ongoing
Tacrolimus Capsules
Reason 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 Terminated
rOPINIRole Tablets USP 5 mg* 100-count bottle
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
rOPINIRole Tablets USP 4 mg* 100-count bottle
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
rOPINIRole Tablets USP 3 mg*
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
rOPINIRole Tablets USP 2 mg*
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
rOPINIRole Tablets USP 1 mg*
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
rOPINIRole Tablets USP 0.5 mg*
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
rOPINIRole Tablets USP 0.25 mg*
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Pravastatin Sodium Tablets USP
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Pravastatin Sodium Tablets USP
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Pravastatin Sodium Tablets USP 20 mg
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Pravastatin Sodium Tablets USP
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Pirfenidone Tablets 801 mg
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Vigabatrin for Oral Solution
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Tadalafil Tablets
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Tadalafil Tablets
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Tadalafil Tablets
Reason CGMP Deviations: recalling drug products following an FDA inspection.