HIGH

Kirkman MAXIMUM ZONE 2 4% Lidocaine Cream Recall for Expiry Stability Issue (2026)

HTO Nevada Inc. dba Kirkman recalled 243 bottles of MAXIMUM ZONE 2, 4% lidocaine cream distributed nationwide by Dermal Source. The recall cites stability data that does not support an expiry date. Consumers and healthcare providers should stop using this product immediately and contact Kirkman for guidance.

Quick Facts at a Glance

Recall Date
February 18, 2026
Hazard Level
HIGH
Brand
HTO Nevada Inc. dba Kirkman
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Stability Data Does Not Support Expiry Date.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact HTO Nevada Inc. dba Kirkman or your healthcare provider for guidance. Notification method: E-Mail

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About This Product

MAXIMUM ZONE 2 4% Lidocaine Cream with epinephrine is a topical anesthetic used for local anesthesia in minor procedures. The product is distributed in 1 oz bottles and carries NDC 80069-015. This recall concerns the stability data not supporting an expiry date.

Why This Is Dangerous

Because expiry dating is not supported by stability data, the product may not provide guaranteed potency or sterility over time. Consumers could receive a product that does not meet labeled performance expectations.

Industry Context

This recall is not described as part of a broader industry pattern in the notice.

Real-World Impact

There is potential risk if patients rely on this product past a true expiry date. No incidents are reported in the recall to date, but consumers should stop use and seek guidance immediately.

Practical Guidance

How to identify if yours is affected

  1. Check NDC 80069-015 on the packaging.
  2. Look for Lot 795CP-0005 and Expiry date 06/30/2026.
  3. Confirm bottle size is 1 oz.

Where to find product info

Recall details are posted on the FDA enforcement page linked in the notice.

What timeline to expect

No timeline is provided for resolution; monitor the FDA page for updates.

If the manufacturer is unresponsive

  • Document all communications with Kirkman
  • File a consumer complaint with FDA if the company is unresponsive
  • Consult your healthcare provider for guidance on alternative products

How to prevent similar issues

  • Verify expiry dates before use of any topical medication.
  • Purchase from reputable pharmacies to ensure valid lot numbers and expiry dates.
  • Keep NDC numbers handy for recalls and replacements.

Documentation advice

Retain product packaging, lot number, expiry date, and all correspondence with the manufacturer for records.

Product Details

NDC: 80069-015. Lot #: 795CP-0005. Expiry date: 06/30/2026. Size: 1 oz bottles. Quantity recalled: 243. Distribution: Nationwide within the United States. Distributor: Dermal Source, Portland, OR 97232.

Key Facts

  • 243 bottles recalled
  • NDC 80069-015
  • Lot 795CP-0005
  • Expiry date 06/30/2026
  • Distributor Dermal Source
  • Nationwide distribution in the U.S.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
6/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeLidocaine Cream with Epinephrine (4% Lidocaine, 0.01% Epinephrine) – 1 oz Bottle
Sold At
Multiple Retailers

Product Details

Model Numbers
795CP-0005
Exp. Date 06/30/2026
Affected States
ALL
Report Date
March 11, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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