Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Min
Summary
The FDA issued a Class III for Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD T by Haleon US Holdings LLC. Reason: 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 Min.
Details
Source
Drug Recall
External ID
D-0592-2025
Action Date
2025-08-27
Status
Ongoing
Category
drug
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/Code Info: Lot # for Case: 5058RB, Exp. date: 08/31/2027 Lot # for Carton and Tube: NJ2A, Exp 08/31/2027
Quantity Affected: 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
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-05
Company
East Durham, NY
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 48 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Haleon US Holdings LLC has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Haleon US Holdings LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Haleon US Holdings LLC have FDA actions?
Haleon US Holdings LLC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0592-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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