MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distrib...
FDA Recall #D-0387-2026 — Class II — February 18, 2026
Product Description
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.
Reason for Recall
Stability Data Does Not Support Expiry Date.
Recalling Firm
HTO Nevada Inc. dba Kirkman — Lake Oswego, OR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
243 bottles
Distribution
Nationwide within the U.S
Code Information
Lot #: 795CP-0005, Exp. Date 06/30/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated