FDA recall D-0345-2026

Agebox · Class II · drug

Product

Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027

Reason for recall

Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren

Distribution

The product was distributed nationwide in the U.S. Agebox sells its U.S. products through Agebox.com (using Shopify) and Amazon.com. All orders are shipped to customers by Agebox itself; other parties are not involved in the distribution of the physical product.

Key facts

Status
Ongoing
Initiation date
2025-10-28
Report date
2026-03-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wilmington, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0345-2026