The Recall Desk
LowFDA (Drugs)·D-0592-2025·Announced 2025-08-27

Sensodyne PRONAMEL Toothpaste Label Mix-up: Tube and Carton Labels Mismatch

Haleon US Holdings is recalling Sensodyne PRONAMEL Fresh Mint toothpaste due to a labeling error where the tube label states 'Cool Mint/Whitening' instead of 'Fresh Mint.' The actual toothpaste inside is Fresh Mint, as indicated on the carton.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall involving a labeling discrepancy where only the tube label is incorrect; the actual product formulation is correct. FDA Class III recalls are typically scored 1 or 2. Without any reported safety hazard, illness, or injury, this labeling-only issue qualifies as Low severity.

Plain-English summary

Haleon US Holdings LLC is recalling Sensodyne PRONAMEL Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint flavor. The recall affects toothpaste tubes distributed nationwide in the United States.

The recall was issued because of a labeling mix-up. The outer carton correctly identifies the product as Fresh Mint, but the tube label incorrectly states 'Cool Mint/Whitening.' The toothpaste inside is actually Fresh Mint, matching the carton label.

The affected product can be identified by the following lot information: Lot # for Case: 5058RB, Lot # for Carton and Tube: NJ2A, with an expiration date of 08/31/2027. Approximately 46,692 tubes were distributed. The product was distributed by GSK Consumer Healthcare, Warren, New Jersey.

The recalled product

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
Manufacturer
Haleon US Holdings LLC
Category
Drug — Oral Care / Toothpaste
Hazard
  • label-mismatch

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot # for Case: 5058RB
  • Exp. date: 08/31/2027 Lot # for Carton and Tube: NJ2A
  • Exp 08/31/2027

Distribution

Distributed nationwide across the United States.

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