Haleon US Holdings LLC: Drug Recall

Recall #D-0592-2025 · 08/05/2025

Class III: Low Risk

Recall Details

Recall Number: D-0592-2025
Classification: Class III
Product Type: Drug
Recalling Firm: Haleon US Holdings LLC
Status: Ongoing
Date Initiated: 08/05/2025
Location: East Durham, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 46,692 tubes

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

Product Description

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

Distribution Pattern

Nationwide in the USA.

Other Recalls by Haleon US Holdings LLC

Class III: Low Risk 12/26/2025

Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Class I: Dangerous 12/26/2023

Microbial Contamination of Non-Sterile Products
Class I: Dangerous 12/26/2023

Microbial Contamination of Non-Sterile Products

View all recalls by Haleon US Holdings LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.