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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- HTO Nevada Inc. dba Kirkman
- Product type
- Lidocaine Cream with Epinephrine (4% Lidocaine, 0.01% Epinephrine) – 1 oz Bottle
- Model numbers
- 795CP-0005, Exp. Date 06/30/2026
- Sizes
- 1 oz
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 18, 2026
Reported by FDA DRUG
March 11, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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.
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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
- Distributor Dermal Source
- Nationwide distribution in the U.S.
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Safety Guide
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