SENSODYNE EXTRA FRESH REPAIR & PROTECT — Class II drug recall D-1323-2015
Terminated recall by GlaxoSmithkline Consmer Healthcare, reported 2015-08-19, distributed nationwide. Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
| Recall number | D-1323-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GlaxoSmithkline Consmer Healthcare, Moon Township, PA, United States |
| Recall initiated | 2015-07-15 |
| Classified | 2015-08-11 |
| Reported by FDA | 2015-08-19 |
| Terminated | 2017-04-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | TW |
| Quantity | 335,676 tubes |
| NDC | 00135-0547, 00135-0547-02, 00135-0548, 00135-0548-01, 00135-0548-02, 00135-0575, 00135-0575-01 |
| Lot numbers | 03/16, 04/16, 05/16, 06/16, 07/15, 08/15, 08/16, 09/15, 10/15, 11/15, 12/15, 12/16, Q3E152, Q3H061, Q3H081, Q3H101, Q3H131, Q3J101, Q3J121, Q3J261, Q3J291, Q3K161, Q3K181, Q3K211, Q3M021, Q3M071, Q3N021, Q3N211, Q4A071, Q4A111, Q4A251, Q4B201, Q4C151, Q4C191, Q4D111, Q4D151, Q4D151R, Q4E151, Q4E151R, Q4F161 and 5 more |
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
Reason for recall
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
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-1323-2015. 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.