FDA Drug Recalls
128 recalls, newest first
Sep 11, 2024
Class II · Moderate risk
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Jul 18, 2024
Class I · High risk
Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Jul 12, 2024
Class I · High risk
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Jul 12, 2024
Class I · High risk
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Jul 12, 2024
Class I · High risk
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Jun 26, 2024
Class II · Moderate risk
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
May 22, 2024
Class II · Moderate risk
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Mar 23, 2024
Class I · High risk
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Mar 23, 2024
Class I · High risk
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Mar 19, 2024
Class I · High risk
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Mar 19, 2024
Class I · High risk
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Mar 19, 2024
Class I · High risk
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Mar 19, 2024
Class I · High risk
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Mar 19, 2024
Class I · High risk
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Mar 19, 2024
Class I · High risk
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Mar 19, 2024
Class I · High risk
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Mar 19, 2024
Class I · High risk
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Mar 19, 2024
Class I · High risk
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Mar 19, 2024
Class I · High risk
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Mar 19, 2024
Class I · High risk
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Feb 6, 2024
Class I · High risk
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Feb 6, 2024
Class I · High risk
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Feb 6, 2024
Class I · High risk
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.
Feb 1, 2024
Class I · High risk
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Feb 1, 2024
Class I · High risk
Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.