Agebox Recalls iKids-Growth Night Formula Due to Undeclared Ibutamoren

FDA Recalls high FDA · · United States

Agebox is recalling iKids-Growth (Night Formula) bottles sold nationwide due to the presence of undeclared ibutamoren and lack of FDA approval.

What Happened

Agebox Inc. has initiated a voluntary recall of its iKids-Growth (Night Formula) dietary supplement. The recall was triggered because the product contains ibutamoren, an undeclared drug ingredient. Furthermore, the FDA determined the product is being marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

Which Products Are Affected

The recall affects the following specific product lots distributed nationwide in the United States through Agebox.com and Amazon.com:

  • Product Name: Agebox iKids-Growth (Night Formula)
  • Format: 60-count bottles
  • UPC: 850065597027
  • Lot # 23101202 (Expiration: 09/2026)
  • Lot # 24080802 (Expiration: 07/2027)
  • Lot # 25020702 (Expiration: 01/2028)

What You Should Do

Consumers who have purchased the affected lots of Agebox iKids-Growth (Night Formula) should immediately discontinue use of the product. The firm originally initiated notification to customers via e-mail. Consumers with questions or those seeking information regarding the return process should contact Agebox Inc. directly.

Why This Matters

This recall is classified as Class II, signifying that the product contains an undeclared drug substance (ibutamoren) and has not been evaluated or approved by the FDA for safety or effectiveness. The presence of undeclared pharmaceutical ingredients in supplements poses a potential health risk to consumers, particularly in products marketed for children.

Source

Information provided by the FDA under recall number D-0345-2026.

Source: FDA Official Notice

Frequently Asked Questions

What is this fda recalls alert about?
Agebox is recalling iKids-Growth (Night Formula) bottles sold nationwide due to the presence of undeclared ibutamoren and lack of FDA approval.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more fda recalls alerts?
Browse all fda recalls alerts on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.