Stannous Fluoride recalls

The FDA has published 6 recalls involving Stannous Fluoride since 2015. The latest was reported on 12 Jul 2017. Most were for foreign material. GlaxoSmithkline Consmer Healthcare has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls6since 2015

Last 12 months0reported

Class I00% of total

Ongoing0latest 12 Jul 2017

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 6 100%Class III 0 0%

Why stannous fluoride is recalled

Foreign Material583%
Other Reasons117%

Companies

Brands

By year

2017233%
2015467%

All stannous fluoride recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
12 Jul 2017Drug	CLASS II	parodontax Whitening (Stannous fluoride) Daily Fluoride recalledParodontax	GSK Consumer Healthcare	Foreign Material	Nationwide
5 Apr 2017Drug	CLASS II	Sensodyne Repair & Protect Whitening recalled by GSK Consumer HealthcareSensodyne	GSK Consumer Healthcare	Other	Nationwide
19 Aug 2015Drug	CLASS II	Sensodyne With Fluoride Repair & Protect, a) tubes recalledSensodyne	GlaxoSmithkline Consmer Healthcare	Foreign Material	Nationwide
19 Aug 2015Drug	CLASS II	Sensodyne Complete PROTECTIONtubes recalled by GlaxoSmithkline ConsmerSensodyne Complete Protection	GlaxoSmithkline Consmer Healthcare	Foreign Material	Nationwide
19 Aug 2015Drug	CLASS II	Sensodyne Extra Fresh Complete Protection tubes recalledSensodyne Complete Protection	GlaxoSmithkline Consmer Healthcare	Foreign Material	Nationwide
19 Aug 2015Drug	CLASS II	Sensodyne Extra Fresh Repair & Protect tubes recalledSensodyne	GlaxoSmithkline Consmer Healthcare	Foreign Material	Nationwide

Should you stop taking Stannous Fluoride?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.