D-0344-2026 Class II Ongoing
FDA drug recall D-0344-2026 was initiated by Agebox on October 28, 2025 and is designated Class II. Reason for recall: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren The recall status is ongoing. Affected quantity: 665 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 4, 2026
- Initiation Date
- October 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 665 bottles
Product Description
Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0
Reason for Recall
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
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.
Code Information
Lot # 23101201 exp 09/2026, 24080801 exp 07/2027, and 25020701 exp 01/2028