Biotene Moisturizing Mouth Spray Recalled for Incorrect Ingredient Labeling
GlaxoSmithKline is recalling Biotene Moisturizing Mouth Spray because the label lists sorbitol, but the product does not contain it.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Moderate because it involves a minor labeling error where an ingredient (sorbitol) is listed on the label but is not present in the product, with no reported injuries or illnesses.
Plain-English summary
GlaxoSmithKline, LLC. is recalling 483,204 bottles of Biotene Moisturizing Mouth Spray, with xylitol, 44.3ml/1.5 FL. OZ. The product is used for the treatment of dry mouth and was distributed nationwide.
The recall was initiated because the product label indicates it is "Sweetened with xylitol and Sorbitol," however, the product does not contain sorbitol. This is a labeling error regarding the ingredients listed on the packaging.
Consumers who have purchased this product should check the lot numbers and UPC. The affected lot numbers are U3E031, U3E151, U3E211, U3F201, U3G031, U3G171, U3G231, and U3G311. The UPC is 048582001558.
The recalled product
- 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
- Manufacturer
- GlaxoSmithKline, LLC.
- Category
- Consumer Product — Oral Care
- Hazard
- Affected units
- 483,204
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- UPC: 048582001558
- Lot numbers U3E031
- U3E151
- U3E211
- U3F201
- U3G031
- U3G171
- U3G231 and U3G311.
Distribution
Distributed nationwide across the United States.
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