Class I · High risk Terminated
Alcohol Antiseptic 80%
Reason Chemical Contamination: FDA testing found Presence of methanol
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Isopropyl Alcohol Antiseptic 75%
Reason CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
Class III · Low risk Terminated
Bevacizumab 2.5 mg/0.1 mL
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Class III · Low risk Terminated
Montelukast Sodium Oral Granules USP
Reason Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Class II · Moderate risk Terminated
Alprazolam Tab
Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Class II · Moderate risk Terminated
Alprazolam Tab
Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Class II · Moderate risk Terminated
Alprazolam Tab
Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Class II · Moderate risk Terminated
Simvastatin 40 mg tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Rosuvastatin 40mg tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Rosuvastatin 10mg tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Rosuvastatin 5mg tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Ropinirole 2mg tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Atorvastatin 20 mg tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Tadalafil 5 mg tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Simvastatin 10 mg tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Rosuvastatin 5mg tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Ropinirole 0.5 mg tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Glimepiride 2 mg tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Doxazosin 2 mg tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Atorvastatin 10 mg tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Aripiprazole 5mg tablets
Reason cGMP Deviations
Class II · Moderate risk Terminated
Glimepiride Tablets
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Glimepiride Tablets
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Glimepiride Tablets
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Verapamil Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications: Out of specification dissolution results above specified values.