FDA recall H-0233-2026

Avion Pharmaceuticals, LLC · Class III · food

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

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.

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.

Key facts

Status
Ongoing
Initiation date
2025-10-29
Report date
2025-12-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=H-0233-2026