FDA (Drugs) recall action 67228
The FDA (Drugs) publishes a recall like this one as 7 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 7 pages.
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of 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.
Schindele Enterprises is recalling XZEN Platinum dietary supplements because they contain undeclared sildenafil and tadalafil, which were marketed without FDA approval.
Schindele Enterprises is recalling Boost Ultra sexual enhancement supplements because they contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Schindele Enterprises is recalling MiracleZEN Platinum dietary supplements because they contain undeclared sildenafil and tadalafil, which were marketed without FDA approval.
Schindele Enterprises is recalling ExtenZe 600 mg tablets because they contain undeclared sildenafil or tadalafil, which were marketed without an approved NDA or ANDA.
Schindele Enterprises is recalling Magic For Men dietary supplements because they contain undeclared sildenafil and tadalafil without FDA approval.
Schindele Enterprises is recalling Sexy Monkey dietary supplements because they contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Schindele Enterprises is recalling XZONE GOLD dietary supplements because they contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.