FDA (Drugs) recall action 94949
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: FDA analysis found products to be tainted with undeclared acetaminophen 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.
Hard Steel Capsules contain undeclared acetaminophen and sildenafil and were marketed without FDA approval. All 729 units distributed nationwide and internationally are included in the recall.
FDA has recalled Gold Hard Steel Plus Liquid because the product was marketed without FDA approval and contains undeclared pharmaceutical ingredients: acetaminophen and sildenafil.