The Recall Desk
ModerateFDA (Drugs)·D-1323-2015·Announced 2015-08-19

Sensodyne Toothpaste Recalled Due to Wood Fragments

GlaxoSmithKline is recalling Sensodyne toothpaste tubes 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 corresponds to a Moderate severity score (2) in the absence of reported injuries or high-risk pathogens, as the hazard is a foreign substance (wood) that may cause temporary or reversible harm.

Plain-English summary

GlaxoSmithKline Consumer Healthcare is recalling 335,676 tubes of Sensodyne Extra Fresh Repair & Protect toothpaste, 3.4 oz. (96.4 g). 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 in Moon Township, Pennsylvania. The recall covers specific lots with expiration dates ranging from July 2015 to August 2016. The product was distributed nationwide, as well as in Puerto Rico and Taiwan.

Consumers should stop using the affected toothpaste and check their lot numbers and expiration dates against the list provided by the manufacturer. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
SENSODYNE (STANNOUS FLUORIDE)
Brand
SENSODYNE
Manufacturer
GlaxoSmithkline Consmer Healthcare
Category
Drug — Oral Care
Hazard
Affected units
335,676

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 # Q3H061
  • Q3H081
  • Q3H101
  • Q3H131
  • Exp 07/15 Q3J101
  • Q3J121
  • Q3J261
  • Q3J291
  • Exp 08/15 Q3K161
  • Q3K181
  • Q3K211
  • Q3M021
  • Exp 09/15 Q3M071
  • QEM251
  • Exp 10/15 Q3N021
  • Q3N211
  • Exp 11/15 Q4A071
  • Q4A111
  • Q4A251
  • Q4B201

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 →

Related recalls

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Same hazard · foreign substance

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