Sensodyne Toothpaste Recalled for Wood Fragments
GlaxoSmithKline is recalling Sensodyne Complete Protection toothpaste because wood fragments were found in the product.
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 the hazard involves a foreign substance (wood fragments) in a dental product. While no injuries are reported, the presence of foreign material in a product used in the mouth presents a moderate risk of injury, fitting the criteria for a moderate severity score.
Plain-English summary
GlaxoSmithKline Consumer Healthcare is recalling 50,860 tubes of Sensodyne Complete Protection (Stannous Fluoride) toothpaste. The recall was initiated because fragments of wood were found when the product was extruded onto a toothbrush.
The affected product is the 3.4 oz. (96.4 g) tube, manufactured by Oratech in South Jordan, Utah, and distributed by GlaxoSmithKline in Moon Township, Pennsylvania. The specific lots involved are C4D061 (Exp 03/16), C4E161 and C4E211 (Exp 04/16), C4F051 (Exp 05/16), and C4H111 (Exp 07/16). The product was distributed nationwide, as well as in Puerto Rico and Taiwan.
Consumers should check their toothpaste tubes for these specific lot numbers and expiration dates. If they have the affected product, they should stop using it and contact the manufacturer for a refund or replacement.
The recalled product
- Product
- SENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE)
- Brand
- SENSODYNE COMPLETE PROTECTION
- Manufacturer
- GlaxoSmithkline Consmer Healthcare
- Category
- Drug — OTC Dental
- Hazard
- Affected units
- 50,860
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 (6)
- Lot # C4D061
- Exp 03/16 C4E161
- C4E211
- Exp 04/16 C4F051
- Exp 05/16 C4H111
- Exp 07/16
Distribution
Part of a larger recall action
This product is one of 8 recalled by GlaxoSmithkline Consmer Healthcare under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same brand · SENSODYNE COMPLETE PROTECTION
- ModerateSensodyne Complete Protection Recalled for Wood Fragments
FDA (Drugs) · 2015-08-19
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FDA (Drugs) · 2015-08-19
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