526 recalls, newest first
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Chemical Contamination
Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which is an active pharmaceutical ingredient in a FDA approved drug used to treat erectile dysfunction (ED).
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.
Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.
Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Chemical Contamination: Bottles may contain broken dessicants
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Labeling; Product Contains Undeclared API (Oxybenzone)