FDA recall D-0554-2026

Product

Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.

Reason for recall

Lack of Assurance of Sterility

Distribution

USA Nationwide

Key facts

Status

Ongoing

Initiation date

2026-05-12

Report date

2026-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wilmington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0554-2026