biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original — Class II drug recall D-1318-2015
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-1318-2015 |
|---|---|
| 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 | 366,192 tubes |
| NDC | 00135-0487-01, 00135-0487-02, 00135-0557, 00135-0557-01, 00135-0557-02, 00135-0558, 00135-0558-01 |
Product
biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.75 oz. (21.3 g) tubes, (NDC 0135-0487-02), c) 4.3 oz. (121.9 g) tubes, (NDC 0135-0557-01), d) 4.5 oz. (127.6 g) tubes, (NDC 0135-0487-01), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
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-1318-2015. 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.