RecallRadar

FDA Drug recall D-1317-2015

biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consume…

On 2015-08-19 the FDA classified a Class II recall of biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consume… 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-1317-2015
ClassificationClass II
Statusterminated
Initiated2015-07-15
Published2015-08-19
Last updated2026-09-13 11:51 UTC
CompanyGlaxosmithkline Consmer Healthcare
DistributionUS

Product

biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01

Reason

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

Identifiers

code_infoLot # Y2J101, Y2J111, Exp 08/15 Y3D031, Exp 02/16

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-1317-2015%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.