Class II · Moderate risk Terminated
Glutathione 200mg/mL Injection w/Pres.
Reason 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
17,898 recalls, newest first
Class II · Moderate risk Terminated
Methyl Folate CA+ 1mg/ml Injection w/Pres.
Reason 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 Terminated
Methylcobalamin 1mg/mL Injection w/Pres.
Reason 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 Terminated
Enalapril Maleate Tablets USP
Reason Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
Class II · Moderate risk Terminated
Acetylcysteine for Injection 6 g/30 mL
Reason CGMP Deviations
Class II · Moderate risk Terminated
eb5 Skincare that Works. Age Spot Treatment. Skin Lightening…
Reason Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination