CLASS III Drug recall · Reported 2 Sep 2020 · FDA Enforcement Report
Red Cross Oral Pain (Oral Anesthetic benzocaine 20%) recalled
The Mentholatum is recalling Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength bottle with Cotton, distributed nationwide in the US. The recall was initiated on 31 Jul 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1541-2020
- FDA event ID
- 86154
- Recalling firm
- The Mentholatum, Orchard Park, NY
- Manufacturer
- The Mentholatum Company
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 31 Jul 2020
- FDA classified
- 24 Aug 2020
- Reported
- 2 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 31 Jul 2020 | Recall initiated by company | |
| 24 Aug 2020 | Classified by FDA | +24 days |
| 2 Sep 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the U.S.
Questions about this recall
Why was it 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 lots are affected?
Item Number: 95090007 Lot #: 66572
Where was it sold?
Nationwide within the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pearson Quality Topical Anesthetic Gel (20% Benzocaine) recalledPearson Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | safco SensiCaine-Ultra (20% Benzocaine) recalled by Keystone IndustriesSafco Sensicaine Ultra Topical Anesthetic Gel | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | Dental City Topical Anesthetic Gel, Benzocaine recalledDental City Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor recalledBurkhart Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | Quala Dental Products, Topical Anesthetic Gel recalledQuala Topical Anesthetic Gel | Keystone Industries | Packaging Defects | Nationwide |