Class IIIOngoing

Sensodyne PRONAMEL (Potassium nitrate 5% recall

FDA recall D-0592-2025 · initiated Aug 5, 2025

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

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

Details

Product: Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK Consumer Healthcare, Warren, NJ 07059. UPC 3 10158 35691 2
Recalling company: Haleon US Holdings
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA.
Initiated: Aug 5, 2025
FDA report date: Aug 27, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0592-2025 ↗

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