PreviDent Toothpaste Recalled for Incorrect Rear Panel Labeling
Colgate is recalling 14,656 bottles of PreviDent 5000 toothpaste because the rear panel is incorrectly labeled with text from a different product.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a cosmetic labeling error.
Plain-English summary
Colgate Palmolive Co is recalling 14,656 bottles of PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE, SLS Free Formula, SOOTHING MINT, 3.4 FL OZ (100 mL). The recall is due to a labeling error where the rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
The affected product is identified by NDC 0126-0016-61 and UPC 3834110622. The specific lot numbers involved are 6350US561G, 6350US562G, 6351US561G, and 6351US562G. The product was distributed nationwide.
Consumers should check their toothpaste bottles for the affected lot numbers and NDC/UPC codes. If the product matches the description, consumers should stop using it and contact Colgate for a refund or replacement. This is a Class III recall, indicating the product is not likely to cause adverse health consequences.
The recalled product
- Product
- PREVIDENT (SODIUM FLUORIDE)
- Brand
- PREVIDENT
- Manufacturer
- Colgate Palmolive Co
- Category
- Drug — Dental
- Hazard
- Affected units
- 14,656
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 (4)
- Lots: 6350US561G
- 6350US562G
- 6351US561G
- 6351US562G
UPCs (1)
- 0301260016610
Distribution
Distributed nationwide across the United States.
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