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Class III · Lower riskActive recall

Sensodyne PRONAMEL (Potassium nitrate 5%

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot # for Case: 5058RB, Exp. date: 08/31/2027 Lot # for Carton and Tube: NJ2A, Exp 08/31/2027
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forGSK Consumer Healthcare, Warren, NJ 07059. UPC 3 10158 35691 2
Show the full FDA record
Full product labelSensodyne 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
Recalling firmHaleon US Holdings LLC
DistributionNationwide in the USA.
Quantity46,692 tubes
Recall initiated2025-08-05
Report date2025-08-27
Recall completed—
Recall numberD-0592-2025
ClassificationClass III
FDA statusOngoing
Origin on fileEast Durham NY United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.