GlaxoSmithKline, LLC.: Medical Device Recall in 2013 - (Recall #: Z-0272-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 17, 2013

Date Posted: November 20, 2013

Recall Number: Z-0272-2014

Event ID: 66689

Reason for Recall:

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

Status: Terminated

Product Quantity: 483,204 bottles

Code Information:

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

Distribution Pattern:

Nationwide Distribution .

Voluntary or Mandated:

Voluntary: Firm initiated