FDA Drug recall D-0624-2017
Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed by Glaxo SmithKline C…
- FDA Drug
- Class II
- terminated
- Published 2017-04-05
On 2017-04-05 the FDA classified a Class II recall of Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz, Distributed by Glaxo SmithKline C… by Gsk Consumer Healthcare, citing presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0624-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-06 |
| Published | 2017-04-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Gsk Consumer Healthcare |
| Distribution | US |
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
Reason
Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
Identifiers
| upc | 310158840602 |
|---|---|
| ndc | 0135-0548-02 |
| ndc | 0135-0548-01 |
| ndc | 0135-0547-02 |
| ndc | 0135-0575-01 |
| code_info | A6J231, expiration 08/2018; A6J261, expiration 08/2018; A6K171, expiration 08/2018; A6K241, expiration, 09/2018; A6M231, expiration 10/2018 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0624-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.