thejoe Stannous Fluoride

Stannous Fluoride recalls: 6 FDA reports

Recalls involving Stannous Fluoride. What was wrong with each batch, and how the FDA graded the risk.

6Reports

0Class I

0Ongoing

2017-07-12Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	6

By year reported

Year	Reports
2015	4
2017	2

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis Toothpaste, 0.454% (0.15

D-0944-2017 · Class II · reported 2017-07-12 · Terminated

Why it was recalled: Presence of Foreign Substance: possibility of the presence of metal in the product.
Product: parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis Toothpaste, 0.454% (0.15% w/v fluoride ion), 3.4 OZ (96.4 g) tube, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059, NDC 0135-0601-01.
Where it went: Nationwide in the USA
How much: 15,708 tubes

Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Dist

D-0624-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
Product: Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed by Glaxo SmithKline Consumer Healthcare LP Moon Township PA 15108 --- NDC 0135-0575-01, UPC UPC: 3 10158 84060 2
Where it went: Nationwide
How much: 56,840 cases

SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84

D-1323-2015 · Class II · reported 2015-08-19 · Terminated

Why it was recalled: Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Product: SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0547-02
Where it went: Nationwide, Puerto Rico & Taiwan
How much: 335,676 tubes

SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufactured by Oratech, South Jordan UTAH 8

D-1321-2015 · Class II · reported 2015-08-19 · Terminated

Why it was recalled: Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Product: SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0572-02
Where it went: Nationwide, Puerto Rico & Taiwan
How much: 50,860 tubes

SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distri

D-1322-2015 · Class II · reported 2015-08-19 · Terminated

Why it was recalled: Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Product: SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0573-02
Where it went: Nationwide, Puerto Rico & Taiwan
How much: 81,376 tubes

SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b) 3.4 oz. (96.4 g) tub

D-1324-2015 · Class II · reported 2015-08-19 · Terminated

Why it was recalled: Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Product: SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b) 3.4 oz. (96.4 g) tubes, (NDC 0135-0548-02) Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
Where it went: Nationwide, Puerto Rico & Taiwan
How much: 325,504 tubes

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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