86 recalls · Class I, newest first
Marketed without an Approved NDA/ANDA: FDA analysis found 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.
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Chemical Contamination: FDA testing found Presence of methanol
Chemical Contamination: FDA testing found Presence of methanol
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Non-Sterility
Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
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.
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.