Haleon US Holdings LLC 2025-08-27 Health moderate FDA
Health · FDA · Recall #FDA-D-0592-2025
Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste… Recall
Issued August 27, 2025 · Haleon US Holdings LLC
In August 2025, Haleon US Holdings LLC recalled the Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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
- 1 Stop using Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Haleon US Holdings LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Haleon US Holdings LLC
- Category
- Health
- Recall date
- August 27, 2025
- Units affected
- Not reported
- Sold at
- Nationwide in the USA.
- Recall number
- FDA-D-0592-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Haleon US Holdings LLC has 3 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.