Recall · openFDA Food Enforcement

Prenate Chewable¿ A chewable Rx prenatal vitamin with a…: FDA Recall H-0233-2026

Agency action: Oct 29, 2025Record ID: H-0233-2026
View official source ↗

What happened

Original notice title

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…

From the archived source record

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.

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

Read the official notice →

Status and source details

Status recorded in the archive
Ongoing
FDA recall classification
Class III
Recall initiated by
Voluntary: Firm initiated
Report date
Dec 10, 2025
Source checked
Jul 16, 2026
Record revision
069b355b77f7

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

Sources, dates, and coverage →

What is affected

Product
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
Company
Avion Pharmaceuticals, LLC
Lot / identifier
Product Code 75854-306-30 Lot 2402036 Exp 2026-04 Lot 2402036A Exp 2026-04 & Lot 2412020 Exp 2027-02
Market / distribution
Product was shipped to the following states: AL, AZ, CA, CO, FL, GA, IA, IL, KY, MA, MO, NY, OH, OK, PA, TX & VA.