FDA (Drugs) recall action 87712
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: Products found to contain undeclared sildenafil and/ or 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.
NSNY Distributor Inc is recalling Ginseng Power 5000 capsules nationwide because they contain undeclared sildenafil and/or tadalafil, prescription medications not listed on the label or approved for sale in this product.
Premium OrgaZEN 7000 capsules distributed nationwide have been recalled because they were marketed without FDA approval and contain undeclared sildenafil and/or tadalafil, prescription drugs that pose serious health risks.