MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR ...

FDA Recall #D-0386-2026 — Class II — February 18, 2026

Recall #D-0386-2026 Date: February 18, 2026 Classification: Class II Status: Ongoing

Product Description

MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.

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

178 bottles

Distribution

Nationwide within the U.S

Code Information

Lot #: 807CP-0003, Exp. Date 07/31/2026.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated