FDA Drug recall D-1320-2015
biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(1…
- FDA Drug
- Class II
- terminated
- Published 2015-08-19
On 2015-08-19 the FDA classified a Class II recall of biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(1… 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-1320-2015 |
| 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 PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
Reason
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Identifiers
| code_info | Lot # a) Z3M191, Exp 10/15 Z4C081, Exp 02/16 Z4H171, Exp 07/16 b) Z2K301, Exp 10/15 Z3D181, Exp 04/16 |
|---|
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-1320-2015%22
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