Children's growth supplement recalled for containing undeclared ibutamoren
Agebox is recalling iKids-Growth (Night Formula) 60-count bottles because the product was marketed without an approved NDA or ANDA and contains undeclared ibutamoren.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of a children's product containing an undeclared pharmacologically active substance, with no illnesses stated in the source.
Plain-English summary
Agebox is recalling Agebox iKids-Growth (Night Formula) in 60-count bottles, UPC 850065597027, manufactured exclusively for Agebox Inc., Wilmington, DE. The FDA has classified this recall as Class II.
The product was marketed without an approved New Drug Application or Abbreviated New Drug Application, and contains undeclared ibutamoren.
The product was distributed nationwide in the United States. Agebox sells its US products through Agebox.com and Amazon.com, and ships all orders itself. Affected lots are 23101202 (expiry 09/2026), 24080802 (expiry 07/2027) and 25020702 (expiry 01/2028).
Consumers can identify affected product by the UPC and lot codes above, and may contact Agebox for further information.
The recalled product
- Product
- Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027
- Manufacturer
- Agebox
- Category
- Drug — Dietary supplement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # 23101202 exp 09/2026
- 24080802 exp 07/2027
- and 25020702 exp 01/2028
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Agebox under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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