3M ESPE Clinpro 5000 Toothpaste Recalled for Missing Lot and Expiration Dates
3M ESPE is recalling 19,728 tubes of Clinpro 5000 Anti-Cavity Toothpaste because the primary boxes are missing lot numbers and expiration dates.
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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling defect (missing lot/exp date) rather than a product safety hazard.
Plain-English summary
3M Company/3M ESPE Dental Products is recalling 19,728 tubes of 3M ESPE Clinpro 5000 (1.1% Sodium Fluoride) Anti-Cavity Toothpaste, 4 oz tube (NDC 48878-3130-04). The product is prescription-only and was distributed nationwide.
The recall was initiated because the subject lot (Lot # 30131, Product Code: 12115SM) is missing the lot number and expiration date stamp on the primary box. This labeling error prevents proper tracking and verification of the product's shelf life.
Consumers and dental professionals should check their inventory for this specific product code and lot number. If found, the product should be returned to the supplier or disposed of according to local regulations. The FDA has classified this as a Class III recall, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- 3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tube (NDC 48878-3130-04), Rx Only, Manufactured for 3M ESPE Dental Products, St. Paul, MN 55144
- Manufacturer
- 3M Company/3m Espe Dental Products
- Category
- Drug — Dental
- Hazard
- Affected units
- 19,728
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 (2)
- Product Code: 12115SM
- Lot # 30131
Distribution
Distributed nationwide across the United States.
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