Sensodyne PRONAMEL (Potassium nitrate 5% recall
FDA recall D-0592-2025 · initiated Aug 5, 2025
Haleon US Holdings LLC recalled Sensodyne PRONAMEL (Potassium nitrate 5% in Aug 2025 — an FDA Class III recall (D-0592-2025) because 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.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
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
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 46,692 tubes
Details
- 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
- Recalling company
- Haleon US Holdings
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- Aug 5, 2025
- FDA report date
- Aug 27, 2025
Frequently asked
- Was Sensodyne PRONAMEL (Potassium nitrate 5% recalled?
- Haleon US Holdings LLC recalled Sensodyne PRONAMEL (Potassium nitrate 5% in Aug 2025 — an FDA Class III recall (D-0592-2025) because 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Sensodyne PRONAMEL (Potassium nitrate 5% recalled?
- Per the FDA enforcement record, the reason for recall D-0592-2025 was: 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
- Is a recalled Sensodyne PRONAMEL (Potassium nitrate 5% dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Sensodyne PRONAMEL (Potassium nitrate 5% are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — Lot # for Case: 5058RB, Exp. date: 08/31/2027 Lot # for Carton and Tube: NJ2A, Exp 08/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0592-2025.