Class III U.S. Food and Drug Administration

Avion Pharmaceuticals, LLC Prenate Chewable¿ A chewable Rx prenatal vitamin recall: Undeclared Soy. The firm received positive test results for soy

Recall published 11 months ago

Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving.

The hazard: Undeclared soy

The product contains soy that the packaging never declared. If nobody in your home avoids soy, there is no health reason to throw it away — though the refund still stands.

What the notice says: Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving.

Why it matters: The label does not declare soy, so anyone who reads labels to avoid it has no way of knowing it is in there. For people without that allergy the product is safe to eat.

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
H-0233-2026
Published
December 10, 2025
Risk level
Class III
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Avion Pharmaceuticals, LLC
Product type
Dietary supplements
Units affected
804 bottles
Distribution
Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Missouri, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia
Made in
United States
Lot / code info
Product Code 75854-306-30 Lot 2402036 Exp 2026-04 Lot 2402036A Exp 2026-04 & Lot 2412020 Exp 2027-02
UPC codes
375854306302

Products covered by this recall

Prenate Chewable¿ A chewable Rx prenatal vitamin with a delicious chocolate flavor with Quatrefolic Dietary Supplement 30 Tablets Rx Only UPC 3 75854 30630 2 Manufactured for: Avion Pharmaceuticals, LLC Alpharetta, GA 30005

Check your product

The notice names 2 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.

  • 375854306302

Best-by / use-by date

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

  • 2027-02 — 804 bottles

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

What to do about Soy

Avion Pharmaceuticals, LLC — The product contains soy that the packaging never declared. If nobody in your home avoids soy, there is no health reason to throw it away — though the refund still stands.

  1. If anyone in your household avoids soy, stop serving the product immediately and check whether any was used in food already prepared.
  2. Keep the pack if you want a refund, or photograph the label and the lot code and then bin it. If nobody in the house avoids soy, you may simply eat it — the recall is about disclosure, not spoilage.
  3. Make sure the household epinephrine auto-injector is where it should be and in date, if someone here carries one.
  4. If a reaction has already happened, report it to the FDA through its consumer complaint coordinator so the case is attached to this recall.

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: Avion Pharmaceuticals, LLC — 1880 Mcfarland Pkwy Ste 105, Alpharetta, GA, 30005-1794

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 — Food & cosmetics enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Avion Pharmaceuticals, LLC dietary supplements recalled?

Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving. Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 375854306302; best-by date 2027-02 — 804 bottles. 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?

If anyone in your household avoids soy, stop serving the product immediately and check whether any was used in food already prepared.

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.

Which states were affected?

The notice lists Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Missouri, New York and others.

Related recalls