H-0233-2026
Avion Pharmaceuticals, LLC
Data retrieved 2026-10-27T22:06:49.008Z
Site-assigned category (for this product recall): Allergen & mislabeling
Independent website; not affiliated with or endorsed by FDA. Recall information is attributed to the linked FDA record. Categories are assigned by this website using keyword rules; they are not FDA classifications or independent legal findings and may be incomplete or incorrect. A category summarizes the stated reason for the identified product recall, not a finding about the firm generally or its other products. FDA’s original reason text appears below.
Official openFDA record · FDA recalls and safety alerts
Fields as reported by FDA
Dates are formatted YYYY-MM-DD. “Not reported” means the field was absent or empty.
- recall_number
- H-0233-2026
- event_id
- 97893
- recalling_firm
- Avion Pharmaceuticals, LLC
- city
- Alpharetta
- state
- GA
- country
- United States
- 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
- 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.
- classification
- Class III
- FDA-reported status (not current status)
- Ongoing
FDA does not update this status after recall classification. It may not reflect whether the recall is currently ongoing, completed, or terminated. - voluntary_mandated
- Voluntary: Firm initiated
- 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.
- product_quantity
- 804 bottles
- code_info
- Product Code 75854-306-30 Lot 2402036 Exp 2026-04 Lot 2402036A Exp 2026-04 & Lot 2412020 Exp 2027-02
- recall_initiation_date
- 2025-10-29
- report_date
- 2025-12-10
- termination_date
- Not reported