FDA recall D-0386-2026

HTO Nevada Inc. dba Kirkman · Class II · drug

Product

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.

Distribution

Nationwide within the U.S

Key facts

Status
Ongoing
Initiation date
2026-02-18
Report date
2026-03-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Oswego, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0386-2026