Drug Enforcement D-0592-2025

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

Status

Ongoing

Classification

Class III

Report Date

August 27, 2025

Termination Date

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Product Information

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
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
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA.

Location & Firm

Recalling firm
Haleon US Holdings LLC
Address
3169 Route 145, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0592-2025
Event ID
97382
Recall initiation date
August 5, 2025
Center classification date
August 19, 2025
Code info
Lot # for Case: 5058RB, Exp. date: 08/31/2027 Lot # for Carton and Tube: NJ2A, Exp 08/31/2027
More code info
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