The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1320-2015·Announced 2015-08-19

Biotene PBF Toothpaste Recalled for Wood Fragments

GlaxoSmithKline is recalling Biotene PBF 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 typically involves a situation that may cause temporary or medically reversible adverse health consequences. The hazard is a foreign substance (wood fragments) in a topical oral care product, which poses a risk of injury but is not a systemic toxicological threat.

Plain-English summary

GlaxoSmithKline Consumer Healthcare is recalling specific lots of Biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula) and Biotene PBF Paste. The recall involves 50,860 tubes of the 4.3 oz. and 4.5 oz. sizes. The products were 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 affected lots include Z3M191, Z4C081, Z4H171, Z2K301, and Z3D181.

Consumers should check their toothpaste tubes for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact the recalling firm for instructions on how to return the product or obtain a refund.

The recalled product

Product
biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare…
Manufacturer
GlaxoSmithkline Consmer Healthcare
Category
Consumer Product — Oral Care
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 # a) Z3M191
  • Exp 10/15 Z4C081
  • Exp 02/16 Z4H171
  • Exp 07/16 b) Z2K301
  • Exp 10/15 Z3D181
  • Exp 04/16

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 →

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