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.
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
- Check NDC 80069-015 on the packaging.
- Look for Lot 795CP-0005 and Expiry date 06/30/2026.
- 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.