Prenatal chewable vitamins recalled over undeclared soy and a boron labeling error
Avion Pharmaceuticals is recalling 804 bottles of Prenate Chewable after positive test results for soy, which is not listed on the label, and a boron amount stated in mg instead of mcg.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the allergen-mislabeling criterion: soy, a major allergen, was detected in the product and is not declared on the label.
Plain-English summary
Prenate Chewable, a chewable prescription prenatal vitamin with chocolate flavour containing Quatrefolic, sold in 30-tablet bottles with UPC 3 75854 30630 2 and manufactured for Avion Pharmaceuticals, LLC of Alpharetta, Georgia, is being recalled.
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.
The recall covers 804 bottles, product code 75854-306-30, from lots 2402036 and 2402036A, both expiring 2026-04, and lot 2412020, expiring 2027-02. The product was shipped to Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Missouri, New York, Ohio, Oklahoma, Pennsylvania, Texas and Virginia. The FDA has classified the action as Class III.
People with a soy allergy can have a reaction after taking a product containing soy when the label does not declare it. Patients should not stop taking a prescribed product without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected.
The recalled product
- 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
- Manufacturer
- Avion Pharmaceuticals, LLC
- Category
- Drug — Prenatal vitamin
- Hazard
- undeclared-soy
- allergen
- labeling-error
- boron-units
Distribution
Distributed in 17 states:
- AL
- AZ
- CA
- CO
- FL
- GA
- IA
- IL
- KY
- MA
- MO
- NY
- OH
- OK
- PA
- TX
- VA
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