CLASS II Drug recall · Reported 12 Jul 2017 · FDA Enforcement Report
parodontax Whitening (Stannous fluoride) Daily Fluoride recalled
GSK Consumer Healthcare is recalling parodontax Whitening (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis, distributed nationwide in the US. The recall was initiated on 28 Jun 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0944-2017
- FDA event ID
- 77651
- Recalling firm
- GSK Consumer Healthcare, Warren, NJ
- Brand
- Parodontax
- Manufacturer
- Haleon US Holdings LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jun 2017
- FDA classified
- 6 Jul 2017
- Reported
- 12 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Sunscreen & Personal Care
Timeline
| 28 Jun 2017 | Recall initiated by company | |
| 6 Jul 2017 | Classified by FDA | +8 days |
| 12 Jul 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: possibility of the presence of metal in the product.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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 was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: possibility of the presence of metal in the product.
Which lots are affected?
G7E101, Exp 04/19
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from GSK Consumer Healthcare
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sensodyne Repair & Protect Whitening recalled by GSK Consumer HealthcareSensodyne | GSK Consumer Healthcare | Other | Nationwide |
| Drug | CLASS III | Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot recalled | GSK Consumer Healthcare | Other | Nationwide |
| Device | CLASS III | Breathe Right recalled by GSK Consumer Healthcare | GSK Consumer Healthcare | Labeling Errors | Nationwide |
Other Stannous Fluoride recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sensodyne Repair & Protect Whitening recalled by GSK Consumer HealthcareSensodyne | GSK Consumer Healthcare | Other | Nationwide |
| Drug | CLASS II | Sensodyne With Fluoride Repair & Protect, a) tubes recalledSensodyne | GlaxoSmithkline Consmer Healthcare | Foreign Material | Nationwide |
| Drug | CLASS II | Sensodyne Complete PROTECTIONtubes recalled by GlaxoSmithkline ConsmerSensodyne Complete Protection | GlaxoSmithkline Consmer Healthcare | Foreign Material | Nationwide |
| Drug | CLASS II | Sensodyne Extra Fresh Complete Protection tubes recalledSensodyne Complete Protection | GlaxoSmithkline Consmer Healthcare | Foreign Material | Nationwide |
| Drug | CLASS II | Sensodyne Extra Fresh Repair & Protect tubes recalledSensodyne | GlaxoSmithkline Consmer Healthcare | Foreign Material | Nationwide |