FDA Recall D-0345-2026
Agebox · Wilmington, DE
Class II Ongoing 198 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0345-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- 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.
- Recall initiated
- 2025-10-28
- Classified by FDA Center
- 2026-02-25
- FDA published
- 2026-03-04
- Recalling firm
- Agebox
- Firm location
- Wilmington, DE
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.