Class II · Moderate risk
Glutathione 200mg/mL Injection w/Pres.
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Class II · Moderate risk
Methyl Folate CA+ 1mg/ml Injection w/Pres.
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Class II · Moderate risk
Methylcobalamin 1mg/mL Injection w/Pres.
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Class III · Low risk
Enalapril Maleate Tablets USP
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
Class II · Moderate risk
Acetylcysteine for Injection 6 g/30 mL
CGMP Deviations
Class II · Moderate risk
eb5 Skincare that Works. Age Spot Treatment. Skin Lightening…
Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination