Prenate Chewable¿ A chewable Rx prenatal vitamin with a delicious chocolate flavor with Quatrefolic Dietary Supplement 3
Summary
The FDA issued a Class III for Prenate Chewable¿ A chewable Rx prenatal vitamin with a delicious chocolate flav by Avion Pharmaceuticals, LLC. 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 th.
Details
Source
Food Recall
External ID
H-0233-2026
Action Date
2025-12-10
Status
Ongoing
Category
food
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
Lot/Code Info: Product Code 75854-306-30 Lot 2402036 Exp 2026-04 Lot 2402036A Exp 2026-04 & Lot 2412020 Exp 2027-02
Quantity Affected: 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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-29
Company
Alpharetta, GA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 36 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Avion Pharmaceuticals, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Avion Pharmaceuticals, LLC have FDA actions?
This is the only FDA action we have on record for Avion Pharmaceuticals, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "H-0233-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for foodRelated Actions
Marketside 12oz Classic Salad UPC:6-81131-32894-4 SKU: 3107
Dole Fresh Vegetables Inc · 2022-03-02
Honey Caramels Blue Raspberry. Product available in 5.87 oz. bag, 1 lb. bag, 3 lb. bag, 6 lb. bag. PLU Code for 5.87 oz.
Queen Bee Gardens, LLC · 2022-07-27
1. Palmer Candy Drizzled Caramel Corn, Item 19271, Net Wt. 16/5oz tubs, UPC 77343 19271 2. Meijer Drizzled Caramel Popco
Palmer & Company · 2024-08-14
ELITE MILK CHOCOLATE COATED RICE CAKES UPC:815871011884 NET WT 2.47OZ (70 g)
ELITE CONFECTIONERY LTD · 2022-06-15
H&NATURAL 2 PACK! BRAZIL SEED 60 PIECES, PURE NATURAL SEMILLA DE BRASIL FOR 60 DAYS, 5 GRAMS PER BOX, 2 BLACK BOXES.
HandNatural · 2024-04-24