Class II · Moderate risk
Lotrimin Af
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Lotrimin Af
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Lotrimin Af
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Class II · Moderate risk
Coppertone Pure & Simple baby 50 Sunscreen Spray
cGMP Deviations
Class II · Moderate risk
Coppertone Pure & Simple kids 50 Sunscreen Spray
cGMP Deviations
Class II · Moderate risk
Coppertone Pure & Simple 50 Sunscreen Spray
cGMP Deviations
Class I · High risk
Coppertone SPORT Sunscreen Spray 50
Chemical contamination; presence of benzene
Class I · High risk
Coppertone SPORT MINERAL 50 Sunscreen Spray
Chemical contamination; presence of benzene
Class I · High risk
Coppertone Pure & Simple baby 50 Sunscreen Spray
Chemical contamination; presence of benzene
Class I · High risk
Coppertone Pure & Simple kids 50 Sunscreen Spray
Chemical contamination; presence of benzene
Class I · High risk
Coppertone Pure & Simple 50 Sunscreen Spray
Chemical contamination; presence of benzene
Class II · Moderate risk
The Natural Dentist Healthy Balance Peppermint Sage
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8
Class III · Low risk
Butalbital
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Class III · Low risk
Butalbital
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
Class II · Moderate risk
Potassium Chloride Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Artesunate for Injection
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Class I · High risk
Glucagon Emergency Kit for Low Blood Sugar
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Class II · Moderate risk
Hydroquinone USP
Finished product specification did not meet USP specifications.
Class II · Moderate risk
Testosterone Cypionate Testosterone Propionate
Lack of Assurance of Sterility
Class II · Moderate risk
AirDuo Digihaler 232/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 113/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 55/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 232/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 113/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS
Lack of Assurance of Sterility