FDA (Drugs) recall action 66043
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil
Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Fabscout Entertainment, Inc. is recalling Evil Root 1200 mg capsules because the product contains undeclared sildenafil and was marketed without FDA approval.
Fabscout Entertainment is recalling 72HP Maximum Potency Male Sexual Enhancement because it contains undeclared sildenafil and was marketed without FDA approval.
Fabscout Entertainment is recalling PRO POWER MAX Natural Energy Enhancer capsules because they contain undeclared sildenafil and tadalafil and were marketed without FDA approval.