Sensodyne Toothpaste Recalled for Foreign Substance and Off-Flavor Complaints
GSK Consumer Healthcare is recalling Sensodyne Repair & Protect Whitening toothpaste due to the presence of a foreign substance and low concentration of patchouli oil, causing off-flavor and scent complaints.
What this means for you
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 FDA Class II and involves a foreign substance and flavoring issue resulting in off-flavor complaints, which aligns with the rubric for moderate severity involving minor labeling or quality issues without reported serious injury.
Plain-English summary
GSK Consumer Healthcare is voluntarily recalling 56,840 cases of Sensodyne Repair & Protect Whitening toothpaste (stannous fluoride 0.45%) nationwide. The recall is due to the presence of a foreign substance and a low concentration of an additional flavoring ingredient, patchouli oil, which resulted in consumer complaints of off-flavor and off-scent.
The affected product is distributed by Glaxo SmithKline Consumer Healthcare LP in Moon Township, PA. The specific lot codes involved are A6J231, A6J261, A6K171, A6K241, and A6M231, with expiration dates ranging from August 2018 to October 2018. The product is identified by NDC 0135-0575-01 and UPC 3 10158 84060 2.
Consumers with this product should stop using it and return it to the place of purchase for a refund. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- SENSODYNE (STANNOUS FLUORIDE)
- Brand
- SENSODYNE
- Manufacturer
- GSK Consumer Healthcare
- Category
- Drug — OTC Oral Care
- Affected units
- 56,840
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 (9)
- A6J231
- expiration 08/2018
- A6J261
- A6K171
- A6K241
- expiration
- 09/2018
- A6M231
- expiration 10/2018
UPCs (1)
- 310158840602
Distribution
Distributed nationwide across the United States.
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