Class IIIOngoingVoluntary: Firm initiated
Avion Pharmaceuticals, LLC: food recall H-0233-2026
Avion Pharmaceuticals, LLC of Alpharetta, GA recalled Prenate Chewable¿ A chewable Rx prenatal vitamin with a delicious chocolate flavor with Quatrefolic Dietary Supplement… 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. The FDA listed it as Class III in its Enforcement Report dated Dec 10, 2025; distribution: Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Missouri, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia.
Record status as published: Ongoing. openFDA data last updated Oct 21, 2026.
Have this product? Check FDA.gov and your retailer. This page reproduces an FDA Enforcement Report record and is not a public alert. Look for the firm's recall notice on the FDA's recalls page, or ask the store where you bought it what to do. If you think you got sick from a food, contact a health care provider.
Recall details
- 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
- 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.
- Codes, lots and dates on the package
- Product Code 75854-306-30 Lot 2402036 Exp 2026-04 Lot 2402036A Exp 2026-04 & Lot 2412020 Exp 2027-02
- 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.
- Recalling firm
- Avion Pharmaceuticals, LLC, Alpharetta, GA
- Classification
- Class III — the FDA uses this class for a situation in which using or being exposed to the product is not likely to cause adverse health consequences.
- Voluntary or mandated
- Voluntary: Firm initiated
- How the firm first notified customers
- Letter
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Dates
| Event | Date |
|---|---|
| Recall initiated by the firm | Oct 29, 2025 |
| Classified by the FDA | Dec 3, 2025 |
| Published in the Enforcement Report | Dec 10, 2025 |
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Sources
- U.S. Food and Drug Administration, openFDA food enforcement reports, recall number H-0233-2026 (openFDA record). Data provided by the U.S. Food and Drug Administration (https://open.fda.gov).
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