Prenatal Vitamin Recalled for Undeclared Soy and Labeling Error
Avion Pharmaceuticals is recalling 804 bottles of Prenate Chewable prenatal vitamin due to undeclared soy not listed on the label and incorrect boron dosage labeling (250mg instead of 250mcg per serving).
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with undeclared allergen (soy) and a boron labeling error. No illnesses or injuries are reported. Soy is not classified as a major FDA allergen, and the absence of reported harm combined with the Class III classification place this in the Moderate range.
Plain-English summary
Avion Pharmaceuticals, LLC is recalling Prenate Chewable, a chewable prenatal vitamin with chocolate flavor containing Quatrefolic. The recall affects 804 bottles due to undeclared soy and an error in boron dosage labeling.
The firm received positive test results for soy, which is not listed on the product label. Additionally, the boron content is listed as 250mg per serving on the label when the correct amount is 250mcg per serving.
The recalled product was distributed to the following states: Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Missouri, New York, Ohio, Oklahoma, Pennsylvania, Texas, and Virginia. The affected lot numbers are 2402036 (expires April 2026), 2402036A (expires April 2026), and 2412020 (expires February 2027).
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
- Hazard
- allergen-soy
- mis-labeling
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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