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
Product description
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
Lot numbers, UPCs & expiration codes
Lot # for Case: 5058RB, Exp. date: 08/31/2027 Lot # for Carton and Tube: NJ2A, Exp 08/31/2027
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0592-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Aug 5, 2025
- FDA report date
- Aug 27, 2025
- Quantity
- 46,692 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Haleon US Holdings LLC
Original FDA data
Every field from FDA enforcement report D-0592-2025, exactly as published.
Show all FDA fields
- City
- East Durham
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 97382
- Address
- 3169 Route 145
- Code information
- Lot # for Case: 5058RB, Exp. date: 08/31/2027 Lot # for Carton and Tube: NJ2A, Exp 08/31/2027
- Postal code
- 12423-1416
- Report date
- Aug 27, 2025
- Product type
- Drugs
- Recall number
- D-0592-2025
- Classification
- Class III
- Recalling firm
- Haleon US Holdings LLC
- Product quantity
- 46,692 tubes
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Aug 5, 2025
- Initial firm notification
- Letter
- Center classification date
- Aug 19, 2025