Class II · Moderate risk
ESTRIOL Suppositories
Penicillin Cross Contamination: potentially contaminated with penicillin
FDA drug recalls in 2015
Every FDA drug recall initiated in 2015, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,733 recalls, newest first.
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
Class II · Moderate risk
Tri-Mix ST9E
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility