Class II · Moderate risk
TRI-MIX 30/1/60 Injectable
Lack of Assurance of Sterility
FDA drug recalls in 2022
Every FDA drug recall initiated in 2022, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,390 recalls, newest first.
Class II · Moderate risk
TRI-MIX 30/1/40 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/1/20 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TRI-MIX 30/1/10 Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Test Cyp/Prop
Lack of Assurance of Sterility
Class II · Moderate risk
Test Cyp/Dhea
Lack of Assurance of Sterility
Class II · Moderate risk
Test Cyp/Dhea
Lack of Assurance of Sterility
Class II · Moderate risk
TEST CYP (Grapeseed)
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin Acetate 1 MG/ML Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
MIC/B12/L-Carn
Lack of Assurance of Sterility
Class II · Moderate risk
MIC/B12 25/50/50/1 MG/ML Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
L-Carnitine 500 mg/mL Injectable
Lack of Assurance of Sterility
Class III · Low risk
ClomiPRAMINE Hydrochloride Capsules
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Class II · Moderate risk
Neomycin Sulfate Tablets
CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
Class I · High risk
PROPOFOL Injectable Emulsion
Presence of particulate matter
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II · Moderate risk
Triamcinolone Acetonide Cream USP
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Class II · Moderate risk
Proton Armor
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Class II · Moderate risk
Proton Armor
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Class II · Moderate risk
Colgate Whitening Mouthwash
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER…
cGMP deviation: Product held outside of appropriate temperature storage conditions.