FDA (Drugs) recall action 87711
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 Approved NDA/ANDA: FDA analysis results obtained the presence of 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.
Hyobin LLC is recalling PremierZen Black 5000 capsules because FDA analysis detected the unapproved drug tadalafil. The product was marketed without an approved NDA or ANDA.
Hyobin LLC is recalling PremierZen Extreme 3000 capsules because FDA analysis found the unapproved drug tadalafil. The product was marketed without an approved NDA or ANDA.
Hyobin LLC is recalling Triple SupremeZen Plus 3500 capsules because FDA analysis found the unapproved drug tadalafil. The product was marketed without an approved NDA or ANDA.