Food recall

Avion Pharmaceuticals, LLC recall: Prenate Chewable A chewable Rx prenatal vitamin with a delicious chocolate flavor with Quatrefolic Dietary Supplement...

Avion Pharmaceuticals, LLC, of Alpharetta, GA, recalled Prenate Chewable A chewable Rx prenatal vitamin with a delicious chocolate flavor with Quatrefolic Dietary Supplement.... The FDA's reason: “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...” The FDA classified it Class III: it is unlikely to cause harm. The company began the recall voluntarily on October 29, 2025, and the FDA first listed it in its Enforcement Report of December 10, 2025. The recall is still going on.

How serious

Class III

It is unlikely to cause harm

Why

Allergen not on the label

Status

Ongoing

The recall

Company
Avion Pharmaceuticals, LLC (Alpharetta, GA)
Reason, in FDA's words
“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.”
Where it was sold
Product was shipped to the following states: AL, AZ, CA, CO, FL, GA, IA, IL, KY, MA, MO, NY, OH, OK, PA, TX & VA.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
97893

The product recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • H-0233-2026 Class III

    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

    Codes: Product Code 75854-306-30 Lot 2402036 Exp 2026-04 Lot 2402036A Exp 2026-04 & Lot 2412020 Exp 2027-02

    Quantity: 804 bottles

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of December 10, 2025.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.