FDA Issues Alert Over Nationwide Recall of Sensodyne Toothpaste

FDA Issues Alert Over Nationwide Recall of Sensodyne

Haleon Offers Refunds After Sensodyne Recall

FDA Classifies Sensodyne Recall as Low Risk

What Happened

The U.S. Food and Drug Administration (FDA) issued a notice following the nationwide recall of more than 40,000 units of Sensodyne Pronamel Active Shield toothpaste for sensitive teeth.

The recall began on August 5, 2025, after it was discovered that tubes labeled as Fresh Mint were incorrectly marked as Cool Mint/Whitening.

Although the outer box was labeled correctly, the error occurred on the internal tube packaging.

FDA Issues Alert Over Nationwide Recall of Sensodyne

Toothpaste Recalled Nationwide as FDA Issues Risk Warning https://t.co/kAIrUxehtc

— Tuck The Frumpers (@realTuckFrumper) August 20, 2025

The FDA classified the Sensodyne recall as Class III, the lowest category of risk.

This means the issue “is not likely to cause adverse health consequences.”

Nevertheless, the measure seeks to ensure transparency and consumer trust in manufacturing and distribution processes.

This was reported by NewsWeek.

What the Risk Classification Means

The FDA classifies recalls into three levels:

Class I: when the product could cause serious harm or even death.

Class II: when the product may cause temporary or medically reversible adverse effects, or when serious harm is unlikely.

Class III: when the product is not expected to cause negative health effects.

In this case, the FDA emphasized that the contents of the Sensodyne tubes subject to the recall are indeed Fresh Mint, as indicated on the box, so there is no health risk. The issue was strictly labeling.

Haleon U.S. Holdings, based in New York and responsible for distribution, voluntarily recalled the products. The affected lots are numbered 5058RB on the boxes and NJ2A on the tubes, with an expiration date of August 31, 2027.

What Consumers Should Do

Haleon, the manufacturer of Sensodyne, confirmed that consumers can continue using the product safely but offered return options for those who prefer to send it back.

The company stated that customers may return the Sensodyne toothpaste and receive a full refund.

A Haleon spokesperson explained that after an internal investigation, the cause of the error was identified and corrective measures were implemented to prevent a recurrence.

“Consumer safety and product quality are our top priorities,” the company said in a statement.

The FDA also reminded consumers to report any issues related to the quality or safety of medications and personal care products. These reports help monitor potential failures in the production, storage, or distribution chain.

For more information or to request a refund, customers can contact Haleon Consumer Support at +1-866-844-2797, available Monday through Friday, 8 a.m. to 6 p.m. ET, or via email at mystory.us@haleon.com.

The Sensodyne toothpaste recall remains listed as “ongoing” on the FDA’s official database.

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