Class II U.S. Food and Drug Administration

Agebox iKids-Growth , 60-count bottles, Manufactured Exclusively recall: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren

Recall published 8 months ago

Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren

The hazard: Undeclared allergen or ingredient

An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

What the notice says: Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren

Why it matters: An ingredient that U.S. law requires to be declared is present but missing from the label. People who avoid that ingredient cannot make a safe choice from the packaging.

Symptoms and when to call a doctor

An undeclared allergen is a danger only to people allergic or intolerant to that ingredient. For everyone else the food is safe. Reactions range from an itchy mouth, hives, stomach cramps or vomiting through to anaphylaxis — swelling of the lips, tongue or throat, a tight chest, wheezing, a sudden drop in blood pressure or collapse. If anaphylaxis is suspected, use an epinephrine auto-injector straight away and call 911, even if the symptoms seem to settle, because a second wave can follow hours later.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0345-2026
Published
March 4, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Agebox
Product type
Prescription & OTC drugs
Units affected
N/A
Distribution
Nationwide
Sold at
Amazon
Made in
United States
Lot / code info
Lot # 23101202 exp 09/2026, 24080802 exp 07/2027, and 25020702 exp 01/2028
UPC codes
850065597027

Products covered by this recall

Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027

Check your product

The notice names 15 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 850065597027

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 23101202 exp 09
  • 2026
  • 24080802 exp 07
  • 2027
  • 25020702 exp 01
  • 2028

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 09
  • 2026
  • 24080802 exp 07
  • 2027
  • 250207
  • 01
  • 2028 — N

Package size

Match the net weight or the piece count on the front of the pack.

  • 60 count

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Allergen

Agebox — An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.
  3. If someone does avoid it, stop serving it and check anything already cooked with it.
  4. Warn anyone else who eats from your kitchen, including schools and childminders.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Company contact: Agebox — 108 W 13th St, Wilmington, DE, 19801-1145

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Agebox prescription & otc drugs recalled?

Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 850065597027; lot code 23101202 exp 09, 2026, 24080802 exp 07; best-by date 09 or 2026. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.

Can I get my money back?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

Where was the recalled product sold?

It was distributed nationwide, including at Amazon.

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