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FDA Drug recall · Reported January 28, 2015

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

Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..

Recall #
D-0376-2015
Affected scope
19,728 tubes
Initiated
December 19, 2014
Verify with FDA Drug →
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3M Company/3m Espe Dental Products recalled 3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tube (NDC 48878… - a low-severity action.

3M ESPE Clinpro 5000 (1.1% Sodium Flouride), Anti-Cavity Toothpaste, 4 oz tube (NDC 48878… was recalled by 3M Company/3m Espe Dental Products in January 28, 2015. Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiratio…. Check the official notice for the remedy. Verify recall #D-0376-2015 with the FDA Drug before acting.

The recall

3M Company/3m Espe Dental Products issued this low-severity FDA Drug recall-Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiratio….

Low
severity level
Class III
classification
January 28, 2015
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0376-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Cosmetics & Personal Care recalls over time

Where this recall sits in its category - 1,371 cosmetics & personal care recalls on record

0100200300400 20052008201120142017202020232026 33
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Low (Class III)
Status Terminated
Recall number D-0376-2015
Date reported January 28, 2015
Date initiated December 19, 2014
Recalling firm 3M Company/3m Espe Dental Products
Firm location Saint Paul, MN
Affected scope 19,728 tubes
Distribution Nationwide.

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-0376-2015) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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. Recalled by 3M Company/3m Espe Dental Products. Units affected: 19,728 tubes.
Why was this product recalled?
Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..
Which agency issued this recall?
This recall was issued by the FDA Drug on January 28, 2015. Severity: Low. Recall number: D-0376-2015.
Where was the recalled product distributed?
Distribution: Nationwide..
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with Ice Pop, D'Dioses Cookies Cream, 1 Bar (81.7 g), with UPC 7… → · All Cosmetics & Personal Care recalls

This recall: FDA Drug, reported January 28, 2015. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026