The Food and Drug Administration (FDA) has issued a Class II recall for Agebox iKids-Growth (Day Formula) capsules (60-count bottles, UPC 8 50065 59701 0). The recall is due to the product being marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), specifically because it contains undeclared ibutamoren. The product was manufactured exclusively for AGEBOX Inc. and distributed nationwide via Agebox.com and Amazon.com.

This action requires Agebox Inc. and its distributors to immediately cease distribution and notify retailers and consumers about the recall. While classified as Class II, indicating that use or exposure may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote, affected parties should take prompt action to remove the product from shelves and inform consumers. The FDA is monitoring the recall process, which is ongoing.