FDA Drugs recall ·
Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active… recall
- Recall number
- D-0592-2025
- Date
- (initiated August 5, 2025)
- Company / brand
- Haleon US Holdings LLC
3169 Route 145, East Durham, NY, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 46,692 tubes
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # for Case: 5058RB, Exp. date: 08/31/2027 Lot # for Carton and Tube: NJ2A, Exp 08/31/2027
Distribution
Nationwide in the USA.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0592-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.