Haleon US Holdings LLC recalls Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mi…

Recall date

August 5, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0592-2025

FDA classification

Class III

Brand / firm

Haleon US Holdings LLC

Sold / distributed

Nationwide in the USA.

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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