Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Sensodyne PRONAMEL (Potassium nitrate 5% Recalled by Haleon US Holdings LLC Due to Labeling: Label Mix-up: The outer carton is labelled...

Date: August 5, 2025
Company: Haleon US Holdings LLC
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Haleon US Holdings LLC directly.

Affected Products

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

Quantity: 46,692 tubes

Why Was This 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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Haleon US Holdings LLC

Haleon US Holdings LLC has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report