Biotene Fluoride Toothpaste (GlaxoSmithKline) – wood fragments (2015)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01
Brand
GlaxoSmithkline Consmer Healthcare
Lot Codes / Batch Numbers
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
Products Sold
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
GlaxoSmithkline Consmer Healthcare is recalling biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Ora due to Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026