FDA (Drugs) recall action 98011
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: presence of undeclared ibutamoren
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.
Agebox is recalling iKids-Growth (Night Formula) 60-count bottles because the product was marketed without an approved NDA or ANDA and contains undeclared ibutamoren.
Agebox is recalling 665 bottles of iKids-Growth Day Formula capsules because they contain undeclared ibutamoren, a drug ingredient not approved for marketing in the U.S.