Class II · Moderate risk
Blephamide
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
FDA Drug Recalls
1,134 recalls, newest first
Class II · Moderate risk
Buprenorphine HCI Injection
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
Class III · Low risk
Minivelle (estradiol Transdermal System)
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Class III · Low risk
Acyclovir Tablets
Presence of Foreign Substance: human hair melded into tablet.
Class III · Low risk
Amoxicillin and Clavulanate Potassium Tablets
Subpotent Drug; Clavulanic Acid
Class II · Moderate risk
Clozapine Tablets USP
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
Amitriptyline HCL Tablets
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
Class I · High risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
Class I · High risk
Phenobarbital Tablets USP
Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
Class III · Low risk
IC-Green (indocyanine green for injection, USP)
Product is being recalled due to low pH value.
Class II · Moderate risk
Estradiol 6 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 10 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 12.5 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 15 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 18 mg pellet
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 20 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 22 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Estradiol 25 mg pellet 99.5% Estradiol USP
CGMP deviations- Lack of Quality Assurance
Class II · Moderate risk
Shield and Protect Moisture Barrier Cream
GMP Deviations; product may not meet cGMP requirements
Class I · High risk
LabidaMAX Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
ZRECT for Women Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Class I · High risk
ENHANCEROL Herbal Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin