Sensodyne Repair & Protect Whitening — Class II drug recall D-0624-2017
Terminated recall by GSK Consumer Healthcare, reported 2017-04-05, distributed nationwide. Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resultin
| Recall number | D-0624-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GSK Consumer Healthcare, Warren, NJ, United States |
| Recall initiated | 2017-03-06 |
| Classified | 2017-03-30 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2018-05-31 |
| Distributed | Nationwide (US) |
| Quantity | 56,840 cases |
| UPC / GTIN / UDI-DI | 00310158840602 |
| NDC | 00135-0547, 00135-0547-02, 00135-0548, 00135-0548-01, 00135-0548-02, 00135-0575, 00135-0575-01 |
| Expiration dates | 2018-08, 2018-09, 2018-10 |
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 for recall
Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0624-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.