RecallRadar

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…

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

AgencyFDA Drug
Recall numberD-1320-2015
ClassificationClass II
Statusterminated
Initiated2015-07-15
Published2015-08-19
Last updated2026-09-13 11:51 UTC
CompanyGlaxosmithkline Consmer Healthcare
DistributionUS

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_infoLot # 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

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.