ACTIVE RECALL — CLASS IIIActive recallH-0233-2026/FDA enforcement

Prenate Chewable¿ a Chewable Rx Prenatal Vitamin with a Delicious Chocolate Flavor With…

What you need to know

Class III
  • What happened

    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…

  • Health risk

    The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. An allergen that is present but missing or incorrect on the label can cause a serious reaction in allergic consumers.

  • Action required

    Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure.

Active recall · classified by the FDAAL, AZ, CA, CO +13 moreMore supplements

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Product identification

Source: FDA FOOD

Brand nameAvion Pharmaceuticals, LLC
Recalling firmAvion Pharmaceuticals, LLCAlpharetta, GA, United States
UPC / barcodes
3 75854 30630 2
Lot / date codes
  • Product Code 75854-306-30 Lot 2402036 Exp 2026-04 Lot 2402036A Exp 2026-04 & Lot 2412020 Exp 2027-02
Distribution area
ALAZCACOFLGAIAILKYMAMONYOHOKPATXVA

Product was shipped to the following states: AL, AZ, CA, CO, FL, GA, IA, IL, KY, MA, MO, NY, OH, OK, PA, TX & VA.

United States

Quantity affected804 bottles
Recall initiationFDA report date: December 10, 2025
FDA recall numberH-0233-2026

Beyond the headline

The recall, in context

Avion Pharmaceuticals, LLC initiated this supplements recall on October 29, 2025. The FDA enforcement report states: 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 FDA report lists distribution as: Product was shipped to the following states: AL, AZ, CA, CO, FL, GA, IA, IL, KY, MA, MO, NY, OH, OK, PA, TX & VA.

The FDA enforcement report describes the reason as: 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.

Prenate Chewable¿ a Chewable Rx Prenatal Vitamin with a Delicious Chocolate Flavor With… was made or distributed by Avion Pharmaceuticals, LLC in Alpharetta, GA, United States. This page reflects FDA report H-0233-2026, dated December 10, 2025.

Why this is a Class III recall

Class III means the product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. In this recall, an allergen that is present but missing or incorrect on the label can cause a serious reaction in allergic consumers.

FDA definition

The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations.

What to do now

  1. 1

    Stop using it

    Do not eat, drink or take the affected product.

  2. 2

    Check the codes

    Compare the UPC and lot code against the table above.

  3. 3

    Return or discard

    Contact the retailer or recalling firm about a refund, and dispose of the product safely.

Consumer safety guide

Undeclared soy

Symptoms to watch for

Hives, swelling, wheezing, vomiting or anaphylaxis can occur in people with a soy allergy.

When symptoms may appear

Reactions can begin within minutes to a few hours after eating the product.

Higher-risk groups

People with a diagnosed soy allergy, especially children and anyone with a history of anaphylaxis.

What to do now

  1. 1Do not eat the product if you have a soy allergy.
  2. 2Seek emergency care for breathing difficulty, throat swelling or other signs of anaphylaxis.
  3. 3Keep the packaging and contact the retailer or manufacturer about a refund.

This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.

Frequently asked

Questions about this recall

What is the Prenate Chewable¿ a Chewable Rx Prenatal Vitamin with a Delicious Chocolate Flavor With… recall?

Avion Pharmaceuticals, LLC recalled Prenate Chewable¿ a Chewable Rx Prenatal Vitamin with a Delicious Chocolate Flavor With… in an FDA Class III enforcement action reported as H-0233-2026. 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…

What should I do if I bought this product?

Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure. Do not eat the product if you have a soy allergy. Seek emergency care for breathing difficulty, throat swelling or other signs of anaphylaxis. Keep the packaging and contact the retailer or manufacturer about a refund.

Is the Avion Pharmaceuticals, LLC recall still active?

Yes. As of the latest FDA enforcement report, this recall is listed as ongoing. Check the official source record for the most current status before making a decision.

Where can I verify this recall?

This page is normalized from the openFDA enforcement record H-0233-2026. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.

Verify before you act.

VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.

Official source

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Record last synced from official openFDA enforcement data on November 14, 2026. Source record: official FDA notice.