Class II · Moderate risk
ESTRIOL Vaginal Gels
Penicillin Cross Contamination: potentially contaminated with penicillin
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
ESTRIOL Suppositories
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
ESTRIOL Vaginal Creams
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
ESTRIOL Capsules
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
HYDROXOCOBALAMIN Injection
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
E3 Cream
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
2-DEOXY-D-GLUCOSE Powder
Penicillin Cross Contamination: potentially contaminated with penicillin
Class III · Low risk
Carb-O-Philic 40 Cream
CGMP Deviation: Poor container closure of the bulk storage container
Class II · Moderate risk
Rifampin for Injection
Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation
Class III · Low risk
Dr Blue Pain Relieving Gel
Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.
Class III · Low risk
Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP)
Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Class II · Moderate risk
Heparin Sodium and 0.9% Sodium Chloride Injection
Subpotent Drug; out of specification results for heparin raw material
Class I · High risk
Smart Lipo Dietary Supplement capsules
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
Class I · High risk
Smart Lipo Dietary Supplement capsules
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
Class II · Moderate risk
Tri-Mix T-50/PGE 2/LIDO 2 0.09/0.32/0.04 Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-50/PGE 2/LIDO 2 0.03/0.18/0.09 Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-50/PGE 1 0.14/0.08 Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-106/PGE 2 0.1/0.14 Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-106
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-105
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-102/PGE 2/LIDO 2 0.06/0.3/0.2 Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-102
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-101
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix SUPER
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility