FDAClass II · Drug · Recalled June 10, 2026

Lidocaine HCl Injection USP recall — Spectra Medical Devices, Llc

Hazard: Lack of Assurance of Sterility

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0554-2026
Brand: Spectra Medical Devices
Classification: Class II
Units affected: 210625 ampules
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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.

Affected products

Lidocaine HCl Injection USP

Companies & origin

Recalling firm location: Wilmington, MA, United States
Firm address: 299 Ballardvale St, Ste 1, 01887-1066

Identifying details (verbatim from the notice)

Product codes / lots: Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.
Distribution: USA Nationwide
Firm notified the public via: Letter
FDA event ID: 98976
Recall initiated: May 12, 2026
FDA classified: June 2, 2026
FDA report date: June 10, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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