FDA (Drugs) recall action 87324
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 Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
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.
The FDA is recalling Adam's Secret Extra Strength 3000 because it contains unapproved drugs tadalafil and sildenafil.
Adam's Secret Extra Strength 1500 is being recalled because FDA analysis found unapproved drugs tadalafil and sildenafil in the product.