Class III · Low risk
busPIRone Hydrochloride Tablets
Subpotent drug
FDA Drug Recalls
560 recalls, newest first
Class II · Moderate risk
Omega-3-Acid
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Class II · Moderate risk
Revitaderm Wound Care
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Class II · Moderate risk
Fungal Fusion ERADICATION Solution
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk
TERPENICOL Antifungal Solution
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk
vite20 Antifungal Cream
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk
TERPENICOL Antifungal Cream
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk
TRIPENICOL S Antifungal Solution
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Class I · High risk
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Class II · Moderate risk
Desmopressin Nasal Spray
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Class II · Moderate risk
Alendronate Sodium Oral Solution
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Class III · Low risk
Lidocaine Wound Gel
Failed PH Specifications
Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk
Delflex
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Class II · Moderate risk
Delflex
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Class II · Moderate risk
Lidocaine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lactated Ringer's Irrigation
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk
0.9 % Sodium Chloride Irrigation
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk
Dextrose Injection USP
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk
Sterile Water for Injection USP
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.