FDA recall D-0658-2026

Asclemed USA Inc. · Class II · drug

Product

Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01.

Reason for recall

Lack of Assurance of Sterility

Distribution

USA Nationwide

Key facts

Status
Ongoing
Initiation date
2026-06-08
Report date
2026-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Torrance, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0658-2026