# FDA recall D-0592-2025

> **Haleon US Holdings LLC** · Class III · drug recall initiated 2025-08-05.

## 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

- **Recall number:** D-0592-2025
- **Recalling firm:** Haleon US Holdings LLC
- **Classification:** Class III
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0592-2025. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/D-0592-2025. Source: US FDA. Licensed CC0.

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