Recalls / Class III
Class IIIH-0233-2026
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
- Type
- Food
- Affected lot / code info
- Product Code 75854-306-30 Lot 2402036 Exp 2026-04 Lot 2402036A Exp 2026-04 & Lot 2412020 Exp 2027-02
- Quantity
- 804 bottles
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.
Recalling firm
- Firm
- Avion Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1880 Mcfarland Pkwy Ste 105, Alpharetta, Georgia 30005-1794
Distribution
- 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.
Timeline
- Recall initiated
- 2025-10-29
- FDA classified
- 2025-12-03
- Posted by FDA
- 2025-12-10
- Status
- Ongoing
Source: openFDA Food Enforcement endpoint. Recall record H-0233-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings.