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Recall Observatory FDA recall evidence

Drug product

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

D-0345-2026

October 28, 2025

Class II

Product summary

Firm
Agebox
Event
Event 98011
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0345-2026

Official wording

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

Code information: Lot # 23101202 exp 09/2026, 24080802 exp 07/2027, and 25020702 exp 01/2028

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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