GlaxoSmithKline (GSK) Consumer Healthcare is recalling 56,840 cases of Sensodyne Repair & Protect Whitening toothpaste because of a low concentration of an additional flavoring ingredient – patchouli oil – that has caused some customers to complain that the product has an off flavor or unusual scent.
The Food and Drug Administration (FDA) has listed the issue as a Class II recall, which is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The recall affects Sensodyne Repair & Protect Whitening, Net Wt. 3.4 oz. The toothpaste was distributed nationwide by GlaxoSmithKline Consumer Healthcare LP. Affected products contain the following information A6J231, expiration 08/2018; A6J261, expiration 08/2018; A6K171, expiration 08/2018; A6K241, expiration, 09/2018; A6M231, expiration 10/2018.
Sensodyne Repair & Whitening Protect is sold in retail stores across the country. It is intended for use twice daily to continuously help repair, strengthen and protect teeth from sensitivity. Pachouli oil is sometimes used as an antiseptic mouthwash and to fight bad breath and is sometimes promoted for dental health.
Any adverse events or quality issues regarding products affected by this recall should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Enforcement Reports