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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Haleon US Holdings, Sensodyne, PRONAMEL, Active SHIELD
- Product type
- Toothpaste
- Model numbers
- Lot 5058RB, Carton/NJ2A, Exp 08/31/2027
- Colors
- Unknown
- Sizes
- 3.4OZ (96.4g) tube
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 5, 2025
Reported by FDA DRUG
August 27, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Verify UPC 3 10158 35691 2 on the package.
- Check case lot 5058RB and carton/tube lot NJ2A.
- 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
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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
- Outer carton label Fresh Mint; Tube label Cool Mint/Whitening
- Carton and Tube Lot NJ2A
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Safety Guide
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