Class I · High risk Ongoing
Robitussin Honey CF Max Non-Drowsy Adult
Reason Microbial Contamination of Non-Sterile Products
FDA Drug Recalls
2,661 recalls, newest first
Class III · Low risk Ongoing
Benzonatate Capsules
Reason Superpotent drug: Assay results were slightly above specification at the time zero point.
Class I · High risk Ongoing
Bleomycin for Injection
Reason Presence of particulate matter: glass
Class I · High risk Ongoing
Atropine Sulfate Injection
Reason Presence of Particulate Matter; identified as glass
Class I · High risk Ongoing
8.4 % Sodium Bicarbonate Injection
Reason Presence of Particulate Matter; identified as glass
Class I · High risk Ongoing
4.2% Sodium Bicarbonate Injection
Reason Presence of Particulate Matter; identified as glass
Class II · Moderate risk Ongoing
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative…
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class II · Moderate risk Ongoing
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative…
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class II · Moderate risk Ongoing
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE…
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class II · Moderate risk Ongoing
Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class II · Moderate risk Ongoing
Good Neighbor Pharmacy
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class II · Moderate risk Ongoing
Selenium Sulfide 2.25% Shampoo
Reason CGMP Deviations: Stability data does not support expiry date.
Class II · Moderate risk Ongoing
Sertraline Tablets
Reason CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Class II · Moderate risk Ongoing
Nystatin 150 Mu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk Ongoing
Nystatin 2 Bu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk Ongoing
Nystatin 500 Mu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk Ongoing
Nystatin 5bu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class I · High risk Ongoing
Magnum XXL 9800
Reason Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
Class I · High risk Ongoing
SANDIMMUNE Oral Solution
Reason Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Class I · High risk Ongoing
Up&Up brand dry eye relief
Reason Non-Sterility
Class I · High risk Ongoing
Rugby brand Lubricating Tears Eye Drops
Reason Non-Sterility
Class I · High risk Ongoing
Lubricant Eye Drops
Reason Non-Sterility
Class I · High risk Ongoing
Multi-action Relief Drops
Reason Non-Sterility
Class I · High risk Ongoing
Lubricant Gel Drops
Reason Non-Sterility
Class I · High risk Ongoing
Lubricant Gel Drops
Reason Non-Sterility