Recalls / Class III

Class IIID-0592-2025

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

Affected lot / code info

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

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

Recalling firm

Firm

Haleon US Holdings LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

3169 Route 145, N/A, East Durham, New York 12423-1416

Distribution

Quantity

46,692 tubes

Distribution pattern

Nationwide in the USA.

Timeline

Recall initiated

2025-08-05

FDA classified

2025-08-19

Posted by FDA

2025-08-27

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0592-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.