The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1319-2015·Announced 2015-08-19

Biotene Sodium Fluoride Toothpaste Recalled for Wood Fragments

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

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, and the hazard involves a foreign substance (wood fragments) in a product used in the mouth, which presents a risk of injury but is not a systemic health threat like a pathogen or allergen.

Plain-English summary

GlaxoSmithKline Consumer Healthcare is recalling 111,892 tubes of Biotene Gentle Formula Fluoride Toothpaste, Gentle Mint, 4.3 oz. The recall was initiated because fragments of wood were found when the product was extruded onto a toothbrush.

The affected product is manufactured by Oratech in South Jordan, Utah, and distributed by GlaxoSmithKline Consumer Healthcare, L.P. in Moon Township, Pennsylvania. The recall covers specific lots with expiration dates ranging from April 2016 to June 2017. The product was distributed nationwide, as well as in Puerto Rico and Taiwan.

Consumers should stop using the affected toothpaste and return it to the place of purchase for a refund or contact the manufacturer for further instructions.

The recalled product

Product
BIOTENE (SODIUM FLUORIDE)
Brand
BIOTENE
Manufacturer
GlaxoSmithkline Consmer Healthcare
Category
Drug — Oral Care
Hazard
Affected units
111,892

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 (11)

  • Lot # Y3E211
  • Exp 04/16 Y3G231
  • Y3G251
  • Exp 06/16 Y3J231
  • Y3N191 Exp 08/16 Y3N171
  • Exp 11/16 Y4A141
  • Exp 12/16 Y4C271
  • Exp 02/17 Y4E131
  • Exp 04/17 Y4G101
  • Exp 05/17 Y4H191
  • Exp 06/17

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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