FDA (Drugs) recall action 65130
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 have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug
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.
Beamonstar Products is recalling SexVoltz All Natural Herbal Supplement because it contains tadalafil, an unapproved drug ingredient.
Beamonstar Products is recalling Velextra All-Natural Herbal Supplement because it contains tadalafil, an unapproved drug ingredient.