HIGH

Haleon US Recall: Sensodyne PRONAMEL Active SHIELD Toothpaste Recalled for Label Mix-Up

Haleon US Holdings recalls 46,692 toothpaste tubes nationwide after a labeling mix-up. The outer carton says Fresh Mint, while the tube is labeled Cool Mint/Whitening; the tube contents are Fresh Mint as carton indicates. Consumers should stop using the product and contact Haleon for guidance.

Quick Facts at a Glance

Recall Date
August 5, 2025
Hazard Level
HIGH
Brands
Haleon US Holdings, Sensodyne, PRONAMEL...
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, PETS

Hazard Information

Labeling: Label Mix-up: 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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Haleon US Holdings LLC or your healthcare provider for guidance. Notification method: Letter

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About This Product

Sensodyne PRONAMEL Active SHIELD toothpaste is designed for sensitive teeth to reduce discomfort and protect enamel. It combines potassium nitrate and sodium fluoride for sensitivity relief.

Why This Is Dangerous

The hazard is labeling inaccuracy. The outer carton label does not match the tube label, which could cause consumer confusion about flavor and intended use.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall reduces consumer confusion and ensures proper labeling. No injuries reported yet.

Practical Guidance

How to identify if yours is affected

  1. Verify UPC 3 10158 35691 2 on the package.
  2. Check case lot 5058RB and carton/tube lot NJ2A.
  3. Look for Exp 08/31/2027 on carton or tube.

Where to find product info

Recall letters from Haleon provide next steps and refund guidance.

What timeline to expect

Refund/replacement guidance will be provided in recall notification letters; timeline not specified in data.

If the manufacturer is unresponsive

  • Document all communications with Haleon
  • Contact FDA if the company remains unresponsive

How to prevent similar issues

  • Always verify outer carton label matches inner tube label before purchase
  • Check UPC codes and expiration dates upon buying
  • Register products for recall alerts when available

Documentation advice

Keep recall letter, take photos of packaging, UPC, lot numbers, and store receipts

Product Details

Brand: Sensodyne PRONAMEL Active SHIELD toothpaste. Quantity: 46,692 tubes. Distribution: Nationwide in the USA. Sold by: Unknown. UPC 3 10158 35691 2. Case lot: 5058RB. Carton/Tube exposure: Exp 08/31/2027. Sold through Haleon distribution, Warren, NJ 07059.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 46,692 tubes recalled
  • UPC 3 10158 35691 2
  • Outer carton label Fresh Mint; Tube label Cool Mint/Whitening
  • Exp 08/31/2027
  • Lot: 5058RB
  • Carton and Tube Lot NJ2A

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERALPREGNANTPETS
Injury Types
ELECTRICALLACERATIONOTHER

Product Details

Model Numbers
Lot 5058RB
Carton/NJ2A
Exp 08/31/2027
Affected States
ALL
Report Date
August 27, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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