HIGH

Avion Pharmaceuticals Recalls Prenate Chewable Vitamins Over Undeclared Soy

Avion Pharmaceuticals recalled 804 bottles of Prenate Chewable vitamins on October 29, 2025, due to undeclared soy. The recall affects consumers in 15 states, including California and Texas. The product also contains a labeling error regarding the amount of boron.

Quick Facts at a Glance

Recall Date
October 29, 2025
Hazard Level
HIGH
Brand
Avion Pharmaceuticals
Category
Food & Beverages
Sold At
Multiple Retailers
Geographic Scope
Nationwide (50 states)
At-Risk Groups
GENERAL

Hazard Information

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 You Should Do

Consumers who have purchased this product should not consume it. Contact Avion Pharmaceuticals, LLC for refund or replacement information. Notification method: Letter

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Product Details

The recalled product is Prenate Chewable, a Rx prenatal vitamin with Quatrefolic dietary supplement. Each bottle contains 30 tablets. Lot numbers affected include 2402036 and 2412020, with expiration dates of April 2026 and February 2027.

The Hazard

The product contains undeclared soy, which poses a risk to individuals with soy allergies. Additionally, the boron content is mislabeled as 250mg per serving instead of the correct amount of 250mcg.

Reported Incidents

No injuries or adverse events have been reported in connection with this recall. The company initiated the recall proactively after discovering the labeling issues.

What to Do

Consumers should not consume the affected product. Contact Avion Pharmaceuticals at the provided URL for refund or replacement information.

Contact Information

For more details, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=H-0233-2026.

Key Facts

  • 804 bottles recalled
  • Undeclared soy poses allergy risk
  • Boron mislabeling issue
  • States affected: AL, AZ, CA, CO, FL, GA, IA, IL, KY, MA, MO, NY, OH, OK, PA, TX, VA
  • Contact Avion Pharmaceuticals for refunds

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Product Code 75854-306-30 Lot 2402036 Exp 2026-04 Lot 2402036A Exp 2026-04 & Lot 2412020 Exp 2027-02
Affected States
Nationwide
Report Date
December 10, 2025
Source Agency
FDA - Food Safety
Recall Status
ACTIVE

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