Class II U.S. Food and Drug Administration

Agebox iKids-Growth capsules, 60-count bottles 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

The food itself is fine. What is wrong is the label, and for the households that rely on that label it is a real risk.

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-0344-2026
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
665 bottles
Distribution
Nationwide
Sold at
Amazon
Made in
United States
Lot / code info
Lot # 23101201 exp 09/2026, 24080801 exp 07/2027, and 25020701 exp 01/2028
UPC codes
850065597010

Products covered by this recall

Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0

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.

  • 850065597010

Lot or batch code

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

  • 23101201 exp 09
  • 2026
  • 24080801 exp 07
  • 2027
  • 25020701 exp 01
  • 2028

Best-by / use-by date

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

  • 09
  • 2026
  • 24080801 exp 07
  • 2027
  • 250207
  • 01
  • 2028 — 665 bottles

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 — The food itself is fine. What is wrong is the label, and for the households that rely on that label it is a real risk.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. Warn anyone else who eats from your kitchen, including schools and childminders.
  3. Report any reaction to the FDA so it is recorded against this recall.
  4. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

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 850065597010; lot code 23101201 exp 09, 2026, 24080801 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?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Where was the recalled product sold?

It was distributed nationwide, including at Amazon.

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