Class III · Low risk
Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE
Incorrect/Undeclared Excipients.
FDA Drug Recalls
6 recalls, newest first
Class I · High risk
WEFUN Capsules 825 mg
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
SOFT HANDS Alcohol Antiseptic 80%
Chemical Contamination: FDA testing found Presence of methanol
Class I · High risk
Alcohol Antiseptic 80%
Chemical Contamination: FDA testing found Presence of methanol
Class II · Moderate risk
Isopropyl Alcohol Antiseptic 75%
CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
Class I · High risk
PrimeZEN Black 6000 capsule
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.