Z-0272-2014Class II

Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free...

Name: Z-0272-2014 Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free...
Creator: GlaxoSmithKline, LLC.
Published: 2013-10-17
License: https://open.fda.gov/license/

GlaxoSmithKline, LLC. / initiated 2013-10-17 / Terminated / root cause: labeling and UDI

FDA source

GlaxoSmithKline, LLC. began a recall of Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol... on 2013-10-17. FDA classified it as Class II and gives the reason as "Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0272-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-17
Posted: 2013-11-13
Terminated: 2017-07-26
Recalling firm: GlaxoSmithKline, LLC.
Product: 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 code: LFD Saliva, Artificial
Reason for recall: Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: GlaxoSmithKline sent an Urgent Medical Device Recall letter dated October 17, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all affected product. If product was further distributed customers were instructed notify their customers of the recall and the actions required. Customers were asked to complete and return the enclosed business replay card even if they have no affected product in their inventory. Customers should complete the return goods packing slip, enclose it with their return goods shipment and affix the return label to the package. Customers with questions should call Customers Service at 1-800-743-4014. For questions regarding this recall call 919-269-1194.
Quantity in commerce: 483,204 bottles
Distribution: Nationwide Distribution .
Product codes and lots: UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0272-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0272-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13

Product code LFD

K123731UnclassifiedBiotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth SprayGlaxosmithkline Consumer Healthcare (Gskch) / cleared 2013-01-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)