FDA (Drugs) recall action 90551
The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
The agency’s own wording, quoted from the enforcement report.
Launch Sequence Aphrodisia Capsules contain undeclared tadalafil, making them an unapproved drug. The recall involves 500 4-count tins distributed nationwide in the USA and Canada.
Launch Sequence Capsules dietary supplement recalled for containing undeclared tadalafil, an FDA-approved pharmaceutical ingredient. The product was marketed without required drug approval.
Launch Sequence Euphoria Capsules have been recalled because the product contains undeclared tadalafil, an unapproved active ingredient. The capsules were distributed nationwide in the USA and Canada.
Launch Sequence Capsules, a dietary supplement sold in 60-count bottles, were recalled because they were marketed without FDA approval as a drug based on label claims.
Launch Sequence Euphoria Capsules were marketed without FDA approval. Consumers should discontinue use immediately and contact the manufacturer.
Loud Muscle Science is recalling Launch Sequence Aphrodisia Capsules because they were marketed without FDA approval. The product was distributed nationwide in the USA and Canada.