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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Over-the-Counter

Sensodyne PRONAMEL Active SHIELD Toothpaste Recalled for Labeling Mix-up

Agency Publication Date: August 19, 2025
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Summary

Haleon US Holdings LLC is recalling 46,692 tubes of Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth. The recall was initiated because the outer carton is correctly labeled as "Fresh Mint," but the toothpaste tube inside is incorrectly labeled as "Cool Mint/Whitening." Despite the label discrepancy on the tube, the toothpaste itself is the Fresh Mint variety indicated on the outer box.

Risk

The risk is considered low because the toothpaste inside matches the outer carton; however, the labeling discrepancy on the tube may cause consumer confusion regarding the flavor or specific whitening properties of the product.

What You Should Do

  1. This recall involves 3.4 oz tubes of Sensodyne PRONAMEL Active SHIELD Toothpaste for Sensitive Teeth with UPC 3 10158 35691 2. Affected units include lot NJ2A printed on the carton and tube, and lot 5058RB on the shipping case, both with an expiration date of 08/31/2027.
  2. If you have health concerns regarding the use of this product, contact your healthcare provider or pharmacist.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth (3.4 oz)
Variants: Fresh Mint, Cool Mint/Whitening
UPC Codes:
310158356912
Lot Numbers:
5058RB (Exp 08/31/2027)
NJ2A (Exp 08/31/2027)

The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97382
Status: Active
Manufacturer: Haleon US Holdings LLC
Sold By: Retail pharmacies; Grocery stores
Manufactured In: United States
Units Affected: 46,692 tubes
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.