The Recall Desk
HighFDA (Drugs)·D-0592-2025·Announced 2025-08-27

[pending] Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensit

Pending LLM rewrite. Source: FDA_DRUG D-0592-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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

The recalled product

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
Manufacturer
Haleon US Holdings LLC
Category
Drug — Drugs

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category