RECALL RECORD — CLASS IIIRecall closedH-0095-2025/FDA enforcement

Nutrilean, Dietary Supplement

What you need to know

Class III
  • What happened

    Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules.

  • 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.

Recall closed · classified by the FDANationwide (US)More supplements

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Product identification

Source: FDA FOOD

Brand namePreventics, INC. Dba Legere Pharmaceuticals
Recalling firmPreventics, INC. Dba Legere PharmaceuticalsScottsdale, AZ, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • 21745-11, 21745-12, 21745-13, 21745-14, 21745-15
Distribution area
Nationwide

Distributed Nationwide in the United States.

United States

Quantity affected94, 190 capsules
Recall initiationFDA report date: July 2, 2025
FDA recall numberH-0095-2025

Beyond the headline

The recall, in context

Preventics, INC. Dba Legere Pharmaceuticals initiated this supplements recall on April 30, 2025. The FDA enforcement report states: Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules. The FDA report lists distribution as: Distributed Nationwide in the United States.

The FDA enforcement report describes the reason as: Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules.

Nutrilean, Dietary Supplement was made or distributed by Preventics, INC. Dba Legere Pharmaceuticals in Scottsdale, AZ, United States. This page reflects FDA report H-0095-2025, dated July 2, 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 lot and date codes 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 allergen

Symptoms to watch for

Hives, swelling, wheezing, coughing, vomiting, abdominal pain or a drop in blood pressure. Anaphylaxis is a medical emergency.

When symptoms may appear

Allergic reactions often begin within minutes to a few hours of eating the allergen.

Higher-risk groups

Anyone with a diagnosed food allergy, especially children, and people with a history of anaphylaxis or asthma.

What to do now

  1. 1Do not eat or serve the affected product if you or anyone in the household has a diagnosed allergy.
  2. 2If symptoms such as swelling, wheezing or breathing difficulty occur, use the person's prescribed emergency plan and call emergency services.
  3. 3Keep the packaging, contact the retailer or manufacturer for a refund, and read the official recall notice for the exact allergen.

For a severe allergic reaction, do not wait for a callback or refund process before seeking emergency care.

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 Nutrilean, Dietary Supplement recall?

Preventics, INC. Dba Legere Pharmaceuticals recalled Nutrilean, Dietary Supplement in an FDA Class III enforcement action reported as H-0095-2025. Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules.

What are the symptoms of Undeclared allergen exposure?

Hives, swelling, wheezing, coughing, vomiting, abdominal pain or a drop in blood pressure. Anaphylaxis is a medical emergency.

How quickly can Undeclared allergen symptoms appear?

Allergic reactions often begin within minutes to a few hours of eating the allergen.

Who is most at risk from Undeclared allergen?

Anyone with a diagnosed food allergy, especially children, and people with a history of anaphylaxis or asthma.

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 or serve the affected product if you or anyone in the household has a diagnosed allergy. If symptoms such as swelling, wheezing or breathing difficulty occur, use the person's prescribed emergency plan and call emergency services. Keep the packaging, contact the retailer or manufacturer for a refund, and read the official recall notice for the exact allergen.

How do I get a refund from Preventics, INC. Dba Legere Pharmaceuticals?

Contact the recalling company or the retailer where you purchased the product, quote the FDA recall number and ask about a refund or replacement. Keep the packaging, lot code and proof of purchase where possible. The FDA does not issue consumer refunds. Reference FDA recall H-0095-2025 and keep the packaging, lot code and proof of purchase if you have them.

Is the Preventics, INC. Dba Legere Pharmaceuticals recall still active?

The FDA lists this recall as recall closed. It remains relevant if you still have the affected product or need to identify a historical recall.

Where can I verify this recall?

This page is normalized from the openFDA enforcement record H-0095-2025. 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

Brand history

More recalls by Preventics, INC. Dba Legere Pharmaceuticals

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