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Class III: unlikely to cause harmOngoing

Avion Pharmaceuticals Prenate Chewable¿ A chewable Rx prenatal Recall

Prenate Chewable¿ A chewable Rx prenatal vitamin with a delicious chocolate flavor with…

Avion Pharmaceuticals, LLC · Alpharetta, GA

Risk level
Class III
Reported by FDA
Dec 10, 2025
Recall ID
H-0233-2026
Check your lot numberHow we source this data

Summary

Avion Pharmaceuticals recalled Prenate Chewable¿ A chewable Rx prenatal starting Oct 29, 2025. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report H-0233-2026 on Dec 10, 2025. 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 instead of 250mcg per serving. Status: Ongoing.

Why it was 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.

Product description

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

Lot numbers, UPCs & expiration codes

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

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.

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
H-0233-2026
Classification
Class III
Status
Ongoing
Recall initiated
Oct 29, 2025
FDA report date
Dec 10, 2025
Quantity
804 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Avion Pharmaceuticals, LLC

Original FDA data

Every field from FDA enforcement report H-0233-2026, exactly as published.

Show all FDA fields
City
Alpharetta
State
GA
Status
Ongoing
Country
United States
Event ID
97893
Address
1880 Mcfarland Pkwy Ste 105
Code information
Product Code 75854-306-30 Lot 2402036 Exp 2026-04 Lot 2402036A Exp 2026-04 & Lot 2412020 Exp 2027-02
Postal code
30005-1794
Report date
Dec 10, 2025
Product type
Food
Recall number
H-0233-2026
Classification
Class III
Recalling firm
Avion Pharmaceuticals, LLC
Product quantity
804 bottles
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
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 initiation date
Oct 29, 2025
Initial firm notification
Letter
Center classification date
Dec 3, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report H-0233-2026, published Dec 10, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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