Drug recall D-0592-2025

Class III Ongoing reported Aug 27, 2025

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

Reason for recall

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

Lots and codes

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

Recall details

Recalling firm
Haleon US Holdings LLC, East Durham, NY
Quantity
46,692 tubes
Distribution
Nationwide in the USA.
Type
Voluntary: Firm initiated
Recall initiated
August 5, 2025