FDA recall D-0385-2026

HTO Nevada Inc. dba Kirkman · Class II · drug

Product

FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.

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-0385-2026