The Recall Desk
ModerateFDA (Drugs)·D-1318-2015·Announced 2015-08-19

Biotene Fluoride Toothpaste Recalled for Wood Fragments

GlaxoSmithKline is recalling Biotene fluoride toothpaste because wood fragments were found in the product. Consumers should stop using the affected tubes.

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 may cause temporary or medically reversible health issues. The hazard is a foreign substance (wood fragments) with no reported injuries, fitting the Moderate criteria for low-risk contamination or precautionary recalls.

Plain-English summary

GlaxoSmithKline Consumer Healthcare is recalling 366,192 tubes of Biotene Gentle Formula Fluoride Toothpaste, Fresh Mint Original. The recall involves four different tube sizes: 0.70 oz, 0.75 oz, 4.3 oz, and 4.5 oz. The product was manufactured by Oratech in South Jordan, Utah, and distributed nationwide, in Puerto Rico, and in Taiwan.

The recall was initiated due to the presence of a foreign substance. Specifically, fragments of wood were found when the product was extruded onto a toothbrush. The source text does not report any illnesses or injuries associated with this defect.

Consumers should stop using the affected toothpaste and check their lot numbers and expiration dates against the list provided by the manufacturer. The affected lots include specific codes such as X3G121, X3H141, and X2H021, with expiration dates ranging from July 2015 to June 2017. Consumers can contact the recalling firm for further instructions or a refund.

The recalled product

Product
BIOTENE (SODIUM FLUORIDE)
Brand
BIOTENE
Manufacturer
GlaxoSmithkline Consmer Healthcare
Category
Drug — Oral Care
Hazard
Affected units
366,192

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 (20)

  • Lot # a) X3G121
  • X3H141
  • Exp 06/16 X3K121
  • Exp 09/16 X4D281
  • Exp 03/17 X4G181
  • Exp 06/17 b) X3C041
  • Exp 01/16 c) X3F032
  • Exp 04/16 X3G101
  • X3G131
  • Exp 06/16 X3H171
  • X3H211
  • X3H291
  • Exp 07/16 X3J271
  • Exp 08/16 X3K021
  • X3K171
  • X3K291
  • Exp 09/16 X3M121
  • Exp 10/16 X3N171
  • Exp 11/16 X4B061
  • X4B081

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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