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Food FDA Class III Ongoing Undeclared allergen

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

Avion Pharmaceuticals, LLC Published Dec 10, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 47/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • If you are allergic or sensitive to the ingredient noted, do not eat it — it could cause a serious reaction.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Avion Pharmaceuticals, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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.

Hazards

Soybeans · primary

Affected products (1)

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

804 bottles

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

Affected areas

AlabamaArizonaCaliforniaColoradoFloridaGeorgiaIllinoisIowaKentuckyMassachusettsMissouriNew YorkOhioOklahomaPennsylvaniaTexasVirginia

Timeline

  1. Initiated
    Oct 29, 2025
  2. Published
    Dec 10, 2025
Recall number
H-0233-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA food enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.