FDA (Drugs) recall action 65892
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: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.
The agency’s own wording, quoted from the enforcement report.
Fabscout Entertainment is recalling Silver Sword capsules because FDA analysis found they contain sildenafil, an undeclared active pharmaceutical ingredient.
Fabscout Entertainment, Inc. is recalling Clalis capsules because FDA analysis found they contain sildenafil, an undeclared active pharmaceutical ingredient.