PlainRecalls
FDA Drug Verify with FDA Drug → Low Class III Terminated

Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Park, NY 14127 NDC 10742-8902-1, UPC 3 10742 09509 8

Reported: September 2, 2020 Initiated: July 31, 2020 #D-1541-2020 31,732 Blister Packs units

The Mentholatum Company issued this FDA Drug recall on September 2, 2020. Classified as Low severity (Class III). Approximately 31,732 Blister Packs units are affected. The recall was issued because: Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the lab…. This recall notice is sourced from official FDA Drug enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Drug action (record #D-1541-2020) was formally reported on September 2, 2020, with the manufacturer initiating the action on July 31, 2020. It is classified under Low severity (Class III), with a current status of Terminated. The Mentholatum Company is listed as the recalling firm, operating out of Orchard Park, NY. Federal records indicate 31,732 Blister Packs units are affected.

The documented reason for this recall is: Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet … Distribution data in the federal record shows the product reached: Nationwide within the U.S.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Low

Units Affected

31,732 Blister Packs

Related Recalls

6

0 from same agency

Product Description

Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Park, NY 14127 NDC 10742-8902-1, UPC 3 10742 09509 8

Reason for Recall

Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.

Details

Recalling Firm
The Mentholatum Company
Units Affected
31,732 Blister Packs
Distribution
Nationwide within the U.S.
Location
Orchard Park, NY

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-1541-2020
Date reported September 2, 2020
Date initiated July 31, 2020
Recalling firm The Mentholatum Company
Units affected 31,732 Blister Packs
Distribution Nationwide within the U.S.

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

Scale of Impact

31,732 Blister Packs units affected — limited or regional distribution scale.

Regional (<10K units)
Multi-state (10K – 100K units) ✓ This recall
Large-scale (100K – 1M units)
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled?
Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Park, NY 14127 NDC 10742-8902-1, UPC 3 10742 09509 8. Recalled by The Mentholatum Company. Units affected: 31,732 Blister Packs.
Why was this product recalled?
Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 2, 2020. Severity: Low. Recall number: D-1541-2020.
Where was the recalled product distributed?
Distribution: Nationwide within the U.S..
How do I check if my product is affected by a recall?
Check the product description and recall number (D-1541-2020) 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.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. Recall severity varies based on the likelihood and degree of potential harm to consumers. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

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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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).