FDAFDA · Food and drugs·Recall number D-0592-2025
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
Published August 27, 2025 · Recall initiated: August 5, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Haleon US Holdings LLC
- Distributor
- Nationwide in the USA.
- Lot
- Lot # for Case: 5058RB, Exp. date: 08/31/2027 Lot # for Carton and Tube: NJ2A, Exp 08/31/2027
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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