FDA (Drugs) recall action 80128
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
The agency’s own wording, quoted from the enforcement report.
Shoreside Enterprises Inc. is recalling Poseidon Xtreme PLATINUM 4500 because FDA analysis found undeclared sildenafil and tadalafil, making it an unapproved drug.
The FDA is recalling 7K capsules distributed by SX Power Co. because they contain undeclared sildenafil and tadalafil, making them unapproved drugs with unestablished safety and efficacy.