HIGH

Haleon US Holdings Recalls Sensodyne Toothpaste Due to Label Mix-Up

Haleon US Holdings recalled 46,692 tubes of Sensodyne PRONAMEL toothpaste on August 5, 2025, due to a labeling mix-up. The outer carton states Fresh Mint while the tube claims Cool Mint/Whitening. The actual product inside is Fresh Mint, leading to potential consumer confusion.

Hazard Information

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 You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Haleon US Holdings LLC or your healthcare provider for guidance. Notification method: Letter

Product Details

The recall involves Sensodyne PRONAMEL Active SHIELD Toothpaste, 3.4 oz tubes. UPC: 3 10158 35691 2. The product was distributed nationwide in the USA.

The Hazard

The labeling inconsistency may confuse consumers regarding the product's intended flavor. The toothpaste inside the tube remains Fresh Mint as indicated on the outer carton.

Reported Incidents

No injuries or incidents have been reported related to this labeling issue. The recall is precautionary.

What to Do

Stop using the product immediately. Contact Haleon US Holdings LLC or your healthcare provider for further guidance.

Contact Information

For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0592-2025.

Key Facts

  • Recall date: August 5, 2025
  • 46,692 tubes affected
  • No reported injuries
  • Labeling issue may cause consumer confusion
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Safety Assessment

Risk LevelHIGH
Severity Score
4/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot # for Case: 5058RB
Exp. date: 08/31/2027 Lot # for Carton and Tube: NJ2A
Exp 08/31/2027
Affected States
ALL
Report Date
August 27, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE
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