FDA recall D-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

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

Distribution

Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2025-08-05

Report date

2025-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Durham, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0592-2025