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LowClass IIITerminated

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
Compiled from official public sources by the editorial team.
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 FDA Drug action (record #D-0376-2015) was formally reported on January 28, 2015, with the manufacturer initiating the action on December 19, 2014. It is classified under Low severity (Class III), with a current status of Terminated. 3M Company/3m Espe Dental Products is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 19,728 tubes.

The documented reason for this recall is: 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.. Distribution data in the federal record shows the product reached: Nationwide.. Distribution scope 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 - 1,360 cosmetics & personal care recalls on record

-1000100200300400 20052008201120142017202020232026 22
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.

Severity

Low

Affected scope

19,728 tubes

Related Recalls

6

3 from same agency

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..
How do I check if my product is affected by a recall?
Check the product description and recall number (D-0376-2015) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.

Nearby Recalls in This Category

Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported January 28, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.