Class II — Potential Health Hazard

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

Biotene Moisturizing Mouth Spray Recalled by GlaxoSmithKline, LLC. Due to Label indicates, "Sweetened with xylitol and Sorbitol", however...

Date: October 17, 2013
Company: GlaxoSmithKline, LLC.
Status: Terminated
Source: FDA (Device)

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, LLC. directly.

Affected Products

Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth

Quantity: 483,204 bottles

Why Was This Recalled?

Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GlaxoSmithKline, LLC.

GlaxoSmithKline, LLC. has 11 total recalls tracked by RecallDetector.

Related Recalls

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