The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1321-2015·Announced 2015-08-19

Sensodyne Toothpaste Recalled for Wood Fragments

GlaxoSmithKline is recalling Sensodyne Complete Protection toothpaste because wood fragments were found in the product.

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 dental product. While no injuries are reported, the presence of foreign material in a product used in the mouth presents a moderate risk of injury, fitting the criteria for a moderate severity score.

Plain-English summary

GlaxoSmithKline Consumer Healthcare is recalling 50,860 tubes of Sensodyne Complete Protection (Stannous Fluoride) toothpaste. The recall was initiated because fragments of wood were found when the product was extruded onto a toothbrush.

The affected product is the 3.4 oz. (96.4 g) tube, manufactured by Oratech in South Jordan, Utah, and distributed by GlaxoSmithKline in Moon Township, Pennsylvania. The specific lots involved are C4D061 (Exp 03/16), C4E161 and C4E211 (Exp 04/16), C4F051 (Exp 05/16), and C4H111 (Exp 07/16). The product was distributed nationwide, as well as in Puerto Rico and Taiwan.

Consumers should check their toothpaste tubes for these specific lot numbers and expiration dates. If they have the affected product, they should stop using it and contact the manufacturer for a refund or replacement.

The recalled product

Product
SENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE)
Brand
SENSODYNE COMPLETE PROTECTION
Manufacturer
GlaxoSmithkline Consmer Healthcare
Category
Drug — OTC Dental
Hazard
Affected units
50,860

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 (6)

  • Lot # C4D061
  • Exp 03/16 C4E161
  • C4E211
  • Exp 04/16 C4F051
  • Exp 05/16 C4H111
  • Exp 07/16

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 →

Related recalls

Same brand · SENSODYNE COMPLETE PROTECTION

Same manufacturer · GlaxoSmithkline Consmer Healthcare

See all →

Same hazard · foreign object

See all →

Similar recalls