Class II · Moderate risk
Ascorbic Acid 500 mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
FDA Drug Recalls
1,969 recalls, newest first
Class II · Moderate risk
Procaine 1% Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Methylcobalamin 1
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Mitomycin 0.3 mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Lipoic Acid 25 mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Glutathione 200 mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Sodium EDTA 150 mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Hydroxyprogesterone 250 mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Dexamethasone 10 mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Dexpanthenol 200 mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Betamethasone 6 mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Baclofen/Bupivacaine 2
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Baclofen 1
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Baclofen 500 mcg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Avastin 1.25 mg/0.05 mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Methotrexate 25mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class I · High risk
Velextra All-Natural Herbal Supplement
Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug
Class I · High risk
SexVoltz All Natural Herbal Supplement
Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug
Class II · Moderate risk
CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit
cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy
Class III · Low risk
HydrOXYzine Hydrochloride Oral Solution
Subpotent; 24 month stability test station
Class II · Moderate risk
DOBUTamine in 5% Dextrose Injection
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.