FDA Drug recall D-1319-2015
biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distri…
- FDA Drug
- Class II
- terminated
- Published 2015-08-19
On 2015-08-19 the FDA classified a Class II recall of biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distri… by Glaxosmithkline Consmer Healthcare, citing presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1319-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-15 |
| Published | 2015-08-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Glaxosmithkline Consmer Healthcare |
| Distribution | US |
Product
biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01
Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Identifiers
| ndc | 0135-0557-01 |
|---|---|
| ndc | 0135-0557-02 |
| ndc | 0135-0558-01 |
| code_info | Lot # Y3E211, Exp 04/16 Y3G231, Y3G251, Exp 06/16 Y3J231,Y3N191 Exp 08/16 Y3N171, Exp 11/16 Y4A141, Exp 12/16 Y…Lot # Y3E211, Exp 04/16 Y3G231, Y3G251, Exp 06/16 Y3J231,Y3N191 Exp 08/16 Y3N171, Exp 11/16 Y4A141, Exp 12/16 Y4C271, Exp 02/17 Y4E131, Exp 04/17 Y4G101, Exp 05/17 Y4H191, Exp 06/17 |
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-1319-2015%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.