Drug FDA Class II Ongoing Failed specifications

MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.

HTO Nevada Inc. dba Kirkman Published Mar 11, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact HTO Nevada Inc. dba Kirkman or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Stability Data Does Not Support Expiry Date.

Hazards

Failed Stability Testing · primary

Affected products (1)

MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.

243 bottles

Code info: Lot #: 795CP-0005, Exp. Date 06/30/2026

Affected areas

Nationwide

Timeline

Initiated

Feb 18, 2026
Published

Mar 11, 2026

Recall number: D-0387-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.