FDA (Drugs) recall action 89558
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: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
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.
MAC DADDY RED Capsules are being recalled because they contain undeclared tadalafil and/or sildenafil without FDA approval. The product was distributed nationwide via Amazon Marketplace.
ABC Sales 1 Inc is recalling MAC DADDY PURPLE Capsules because they contain undeclared tadalafil and/or sildenafil, active ingredients in FDA-approved prescription drugs, making the product an unapproved drug.