Class IIIFood recall: undeclared soy
Prenate Chewable A chewable Rx prenatal vitamin with a delicious chocolate flavor…
Avion Pharmaceuticals, LLC, of Alpharetta, GA, began recalling this product on . FDA classified the recall as Class III on .
Why it was recalled
In FDA’s words:
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.
The allergen tags on this page are ours, matched from FDA’s words above.
The product
Prenate Chewable A chewable Rx prenatal vitamin with a delicious chocolate flavor…
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
- Codes and dates
- Product Code 75854-306-30 Lot 2402036 Exp 2026-04 Lot 2402036A Exp 2026-04 & Lot 2412020 Exp 2027-02
- Quantity
- 804 bottles
- Recall number
- H-0233-2026
Where it was distributed
In FDA’s words:
Product was shipped to the following states: AL, AZ, CA, CO, FL, GA, IA, IL, KY, MA, MO, NY, OH, OK, PA, TX & VA.
What Class III means
In FDA’s definitions, a Class III recall is one where: use of or exposure to the product is not likely to cause adverse health consequences. FDA’s recall definitions
If you have this product
- FDA’s enforcement report doesn’t say what to do with a recalled product. FDA posts some companies’ recall announcements on its Recalls, Market Withdrawals and Safety Alerts page; not every recall has one.
- FDA doesn’t update a recall’s status after classifying it, so this page can’t tell you whether the recall is still open.
- If someone has a serious allergic reaction, call 911. Signs of a serious reaction
Source
FDA’s Enforcement Report, read through openFDA. This recall first appeared in the report of . openFDA asks that its data not be relied on for decisions about medical care. AllergyNest isn’t affiliated with or endorsed by FDA.