Class II · Moderate risk
CONTRAVE (naltrexone HCl and bupropion HCl)
Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
SUCRETS Sore Throat & Cough Vapor Cherry lozenges
Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was applied to the underside of the Sucrets Sore Throat & Cough Vapor Cherry lozenges tin.
Class II · Moderate risk
Mycophenolic Acid Delayed-release Tablets
Failed Dissolution Specifications: Low out of specification dissolution results.
Class III · Low risk
Magnesium Sulfate Injection
Failed pH Specifications: 12 month stability testing
Class II · Moderate risk
Estradiol Cypionate
Lack of Assurance of Sterility
Class II · Moderate risk
DMSO (Sterile Water)
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin D3
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Tetradecyl Sulfate
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Tetradecyl
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Hyaluronate
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Hyaluronate
Lack of Assurance of Sterility
Class II · Moderate risk
Nanpyridoxine
Lack of Assurance of Sterility
Class II · Moderate risk
Nandrolone Decanoate
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxyzine Hydrochloride
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxyzine Hydrochloride
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxyprogesterone Caproate
Lack of Assurance of Sterility
Class II · Moderate risk
GLYCERIN (Sterile Water)
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione 200mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol Valerate
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol Valerate
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol Cypionate
Lack of Assurance of Sterility
Class II · Moderate risk
Cyanocobalamin
Lack of Assurance of Sterility
Class II · Moderate risk
MD-Gastroview
Labeling: incorrect or missing lot number and/or expiration date
Class II · Moderate risk
Alprostadil
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Class II · Moderate risk
Trimix (Pge1;phent;pap)
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection