CLASS II Device recall · Reported 20 Nov 2013 · FDA Enforcement Report

Biotene Moisturizing Mouth Spray, with xylitol recalled

GlaxoSmithKline is recalling Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief/, Sugar Free, distributed nationwide in the US. The recall was initiated on 17 Oct 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.

Quantity recalled483,204 bottles

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0272-2014
FDA event ID: 66689
Recalling firm: GlaxoSmithKline, Zebulon, NC
Classification: Class II
Status: Terminated
Recall initiated: 17 Oct 2013
FDA classified: 13 Nov 2013
Reported: 20 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Hip & Knee Implants

Timeline

17 Oct 2013	Recall initiated by company
13 Nov 2013	Classified by FDA	+27 days
20 Nov 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution .

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.

Where was it sold?

Nationwide Distribution .

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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