Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original Recalled by GlaxoSmithkline Consmer Healthcare Due to Presence of Foreign Substance: Fragments of wood found...

Date: July 15, 2015
Company: GlaxoSmithkline Consmer Healthcare
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GlaxoSmithkline Consmer Healthcare directly.

Affected Products

biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.75 oz. (21.3 g) tubes, (NDC 0135-0487-02), c) 4.3 oz. (121.9 g) tubes, (NDC 0135-0557-01), d) 4.5 oz. (127.6 g) tubes, (NDC 0135-0487-01), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108

Quantity: 366,192 tubes

Why Was This Recalled?

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GlaxoSmithkline Consmer Healthcare

GlaxoSmithkline Consmer Healthcare has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report