FDAHealthAugust 5, 2025

Haleon US Holdings LLC — 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 c

⚠️ 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

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: August 5, 2025

Nationwide in the USA.

What's affected?

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
Brand: Haleon US Holdings LLC
Lot code: for

Additional details

Lot # for Case: 5058RB, Exp. date: 08/31/2027 Lot # for Carton and Tube: NJ2A, Exp 08/31/2027

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 46,692 tubes.

View original FDA notice →

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