CLASS II Drug recall · Reported 5 Apr 2017 · FDA Enforcement Report
Sensodyne Repair & Protect Whitening recalled by GSK Consumer Healthcare
GSK Consumer Healthcare is recalling Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), distributed nationwide in the US. The recall was initiated on 6 Mar 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-0624-2017
- FDA event ID
- 76662
- Recalling firm
- GSK Consumer Healthcare, Warren, NJ
- Brand
- Sensodyne
- Manufacturer
- Haleon US Holdings LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Mar 2017
- FDA classified
- 30 Mar 2017
- Reported
- 5 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 6 Mar 2017 | Recall initiated by company | |
| 30 Mar 2017 | Classified by FDA | +24 days |
| 5 Apr 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; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
Product as listed by the FDA
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 was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
Which lots are affected?
A6J231, expiration 08/2018; A6J261, expiration 08/2018; A6K171, expiration 08/2018; A6K241, expiration, 09/2018; A6M231, expiration 10/2018
Where was it sold?
Nationwide
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 | parodontax Whitening (Stannous fluoride) Daily Fluoride recalledParodontax | GSK Consumer Healthcare | Foreign Material | 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 | parodontax Whitening (Stannous fluoride) Daily Fluoride recalledParodontax | GSK Consumer Healthcare | Foreign Material | 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 |