The Recall Desk
ModerateFDA (Drugs)·D-1317-2015·Announced 2015-08-19

Biotene Gentle Mint Gel Recalled for Wood Fragments

GlaxoSmithKline is recalling Biotene Gentle Mint Gel tubes because wood fragments were found in the product. Consumers should stop using the affected lots.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a foreign substance (wood fragments) without reported injuries, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

GlaxoSmithKline Consumer Healthcare is recalling 30,516 tubes of Biotene Gentle Mint Gel, 4.5 oz. (127.6 g), manufactured by Oratech. The recall is due to the presence of foreign substances, specifically fragments of wood, which were found when the product was extruded onto a toothbrush.

The affected product is distributed nationwide, in Puerto Rico, and in Taiwan. The recall includes specific lots: Y2J101 and Y2J111 (expiration date 08/15) and Y3D031 (expiration date 02/16). The product is identified by NDC 0135-0488-01.

Consumers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, consumers should stop using it and contact GlaxoSmithKline for further instructions.

The recalled product

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
Manufacturer
GlaxoSmithkline Consmer Healthcare
Category
Drug — Oral Care
Hazard
Affected units
30,516

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot # Y2J101
  • Y2J111
  • Exp 08/15 Y3D031
  • Exp 02/16

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 8 recalled by GlaxoSmithkline Consmer Healthcare under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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