Biotene Moisturizing Mouth Spray, with xylitol, For dry… recallZ-0272-2014 · GlaxoSmithKline, LLC. · initiated Oct 17, 2013
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GlaxoSmithKline, LLC. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-0272-2014
- Status
- Terminated
- Initiated by the company
- Oct 17, 2013
- Posted by the FDA
- Nov 13, 2013
- Recalling firm
- GlaxoSmithKline, LLC.
- Quantity
- 483,204 bottles
- Product code
- LFD
- FDA submissions
- K123731
- Distribution
- Nationwide Distribution .
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
Code information (models, lots, serial numbers)
UPC: 048582001558, Lot numbers U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231 and U3G311.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Biotene Mouth SprayHaleon US Holdings LLC · Saliva, Artificial1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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