Class II · Moderate risk
Selenium Sulfide 2.25% Shampoo
CGMP Deviations: Stability data does not support expiry date.
FDA Drug Recalls
316 recalls, newest first
Class II · Moderate risk
Sertraline Tablets
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Class II · Moderate risk
Nystatin 150 Mu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 2 Bu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 500 Mu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 5bu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class I · High risk
Magnum XXL 9800
Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Class I · High risk
Up&Up brand dry eye relief
Non-Sterility
Class I · High risk
Rugby brand Lubricating Tears Eye Drops
Non-Sterility
Class I · High risk
Lubricant Eye Drops
Non-Sterility
Class I · High risk
Multi-action Relief Drops
Non-Sterility
Class I · High risk
Lubricant Gel Drops
Non-Sterility
Class I · High risk
Lubricant Gel Drops
Non-Sterility
Class I · High risk
CVS Health brand Mild Moderate Lubricating Eye Drops
Non-Sterility
Class I · High risk
Lubricant Eye Drops
Non-Sterility
Class I · High risk
EQUATE brand Hydration PF Lubricant Eye Drops
Non-Sterility
Class I · High risk
Velocity Pharma brand Lubricating Eye Drop
Non-Sterility
Class I · High risk
Leader brand Lubricant Eye Drops
Non-Sterility
Class I · High risk
Target brand High Performance Lubricant Eye Drops
Non-Sterility
Class I · High risk
Leader brand Dry Eye Relief
Non-Sterility
Class I · High risk
CVS Health brand
Non-Sterility
Class I · High risk
Leader brand Eye Irritation Relief
Non-Sterility
Class I · High risk
CVS brand Multi Action Relief Drops
Non-Sterility
Class I · High risk
Leader brand Dry Eye Relief
Non-Sterility