Lower riskDrug recall · FDA · Published August 5, 2025
Sensodyne PRONAMEL Toothpaste Label Mix-Up: Fresh Mint vs Cool Mint/Whitening
Haleon recalls Sensodyne PRONAMEL toothpaste due to outer carton labeling as Fresh Mint but tube labeled Cool Mint/Whitening, causing confusion for consumers.
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
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Contact the company
📍Recalling firmHaleon US Holdings LLC3169 Route 145 · East Durham, NY 12423-1416
✎ GovInfoNow plain-language explainer
Haleon is recalling Sensodyne PRONAMEL toothpaste because the outer carton says 'Fresh Mint' while the tube says 'Cool Mint/Whitening', even though the toothpaste inside is Fresh Mint. This mix-up could confuse customers about which flavor they're getting. Read more at govinfonow.com/recall/31885-sensodyne-pronamel-toothpaste-label-mix-up-fresh-mint-vs-cool.
“Sensodyne PRONAMEL Toothpaste Label Mix-Up: Fresh Mint vs Cool Mint/Whitening.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/31885-sensodyne-pronamel-toothpaste-label-mix-up-fresh-mint-vs-cool. Based on FDA recall #D-0592-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0592-2025%22&limit=1).
Haleon US Holdings LLC, with FDA assistance, is recalling Sensodyne PRONAMEL toothpaste due to a labeling mix-up that may cause consumer confusion. The Food and Drug Administration announced the Class III recall on August 5, 2025.
How to tell if you have it
Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh
UPC 3 10158 35691 2
Lot # for Case: 5058RB
Lot # for Carton and Tube: NJ2A
The hazard
The outer carton is labeled Fresh Mint, but the tube is labeled Cool Mint/Whitening. The toothpaste inside matches the outer carton's Fresh Mint description.
Context
GovInfoNow's records show Haleon US Holdings LLC has had four other recalls since December 26, 2023. On June 4, 2026, Haleon recalled Gas-X Extra Strength Softgels due to chemical contamination risk from a machine leakage. Other recent recalls of similar products include Winder Morphine Sulfate Oral Solution Recall (November 26, 2025).
How to tell if you have this one
Check for Sensodyne PRONAMEL toothpaste with the outer carton labeled 'Fresh Mint' and the tube labeled 'Cool Mint/Whitening', even though the toothpaste inside is Fresh Mint. The product comes in a 3.4oz tube, 6 tubes per case, with UPC 3 10158 35691 2.
Brand
Haleon
Product
Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Labeling
Look for the outer carton labeled 'Fresh Mint' and the tube labeled 'Cool Mint/Whitening' to confirm the mix-up.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 22 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0592-2025 (August 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0592-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.