CLASS III ONGOING Drug recall · Reported 27 Aug 2025 · FDA Enforcement Report
Sensodyne Pronamel (Potassium nitrate recalled by Haleon US Holdings
Haleon US Holdings is recalling Sensodyne Pronamel (Potassium nitrate 5%, Sodium fluoride 0.25%) Active Shield Toothpaste, distributed nationwide in the US. The recall was initiated on 5 Aug 2025 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0592-2025
- FDA event ID
- 97382
- Recalling firm
- Haleon US Holdings, East Durham, NY
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 5 Aug 2025
- FDA classified
- 19 Aug 2025
- Reported
- 27 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Sunscreen & Personal Care
Timeline
| 5 Aug 2025 | Recall initiated by company | |
| 19 Aug 2025 | Classified by FDA | +14 days |
| 27 Aug 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it 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
Which lots are affected?
Lot # for Case: 5058RB, Exp. date: 08/31/2027 Lot # for Carton and Tube: NJ2A, Exp 08/31/2027
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Haleon US Holdings
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Gas-X Extra Strength, Simethicone 125 mg/Antigas recalled | Haleon US Holdings | Packaging Defects | Nationwide |
| Drug | CLASS II | Gas-X, Simethicone 125 mg/ Antigas recalled by Haleon US Holdings | Haleon US Holdings | Other | Nationwide |
| Drug | CLASS III | parodontax (cetylpyridinium chloride)Active Gum Health recalledParodontax | Haleon US Holdings | Other | Nationwide |
| Drug | CLASS I | Robitussin Honey CF Max Non-Drowsy Adult recalled by Haleon US Holdings | Haleon US Holdings | Sterility | Nationwide |
| Drug | CLASS I | Robitussin Honey CF Max Nighttime Adult recalled by Haleon US Holdings | Haleon US Holdings | Sterility | Nationwide |