Biotene Moisturizing Mouth Spray — Class II medical device recall Z-0272-2014
Terminated recall by GlaxoSmithKline, LLC., reported 2013-11-20, distributed nationwide. Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.
| Recall number | Z-0272-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GlaxoSmithKline, LLC., Zebulon, NC, United States |
| Recall initiated | 2013-10-17 |
| Classified | 2013-11-13 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2017-07-26 |
| Distributed | Nationwide (US) |
| Quantity | 483,204 bottles |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00048582001558 |
| Lot numbers | U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231, U3G311 |
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
Reason for recall
Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0272-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.