CLASS III ONGOING Food recall · Reported 10 Dec 2025 · FDA Enforcement Report
Prenate Chewable¿ A chewable Rx prenatal vitamin recalled
Avion Pharmaceuticals is recalling Prenate Chewable¿ A chewable Rx prenatal vitamin with a delicious chocolate flavor with, distributed in 17 states. The recall was initiated on 29 Oct 2025 and the FDA has classified it as Class III.
Check your package
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
Recall details
- Recall number
- H-0233-2026
- FDA event ID
- 97893
- Recalling firm
- Avion Pharmaceuticals, Alpharetta, GA
- Brand
- Prenate Chewable
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 29 Oct 2025
- FDA classified
- 3 Dec 2025
- Reported
- 10 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Undeclared Soy
- Product category
- Vitamins
Timeline
| 29 Oct 2025 | Recall initiated by company | |
| 3 Dec 2025 | Classified by FDA | +35 days |
| 10 Dec 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Product was shipped to the following states: AL, AZ, CA, CO, FL, GA, IA, IL, KY, MA, MO, NY, OH, OK, PA, TX & VA.
AlabamaArizonaCaliforniaColoradoFloridaGeorgiaIowaIllinoisKentuckyMassachusettsMissouriNew YorkOhioOklahomaPennsylvaniaTexasVirginia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Product Code 75854-306-30 Lot 2402036 Exp 2026-04 Lot 2402036A Exp 2026-04 & Lot 2412020 Exp 2027-02
Where was it sold?
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 should I do if I have it?
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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