Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE
Summary
The FDA issued a Class II for Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclu by Agebox. Reason: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren.
Details
Source
Drug Recall
External ID
D-0344-2026
Action Date
2026-03-04
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot # 23101201 exp 09/2026, 24080801 exp 07/2027, and 25020701 exp 01/2028
Quantity Affected: 665 bottles
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-28
Company
Wilmington, DE
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 39 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Agebox has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Agebox) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Agebox have FDA actions?
Agebox has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0344-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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