The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1324-2015·Announced 2015-08-19

Sensodyne Toothpaste Recalled Due to Wood Fragments

GlaxoSmithKline is recalling 325,504 tubes of Sensodyne toothpaste because wood fragments were found when the product was extruded.

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, which corresponds to a moderate severity score for a foreign substance hazard where no specific injuries are reported in the source text.

Plain-English summary

GlaxoSmithKline Consumer Healthcare is recalling 325,504 tubes of Sensodyne With Fluoride Repair & Protect toothpaste. The recall was initiated because fragments of wood were found when the product was extruded onto a toothbrush.

The affected product includes 0.8 oz. (23 g) and 3.4 oz. (96.4 g) tubes manufactured by Oratech in South Jordan, Utah, and distributed by GlaxoSmithKline in Moon Township, Pennsylvania. The recall covers lots distributed nationwide, in Puerto Rico, and in Taiwan.

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

The recalled product

Product
SENSODYNE (STANNOUS FLUORIDE)
Brand
SENSODYNE
Manufacturer
GlaxoSmithkline Consmer Healthcare
Category
Drug — OTC Oral Care
Hazard
Affected units
325,504

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) R3J181
  • Exp 08/15 R4A191
  • R4A192
  • R41291
  • R4B011
  • Exp 12/15 R4C111
  • Exp 02/16 Lot # b) R3G291
  • R3H011
  • Exp 06/15 R3H191
  • R3H261
  • R3H291
  • Exp 07/15 R3J171
  • R3J182
  • R3J191
  • R3J241
  • Exp 08/15 R3K031
  • R3K121
  • R3K221
  • R3K291
  • Exp 09/15 R3M111

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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