Home / Recalls / Spectra Medical Devices, Llc / D-0554-2026

D-0554-2026 Class II Ongoing

Recalled by Spectra Medical Devices, Llc — Wilmington, MA

Recall Details

Product Type: Drugs
Report Date: June 10, 2026
Initiation Date: May 12, 2026
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 210625 ampules

Product 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.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

USA Nationwide

Code Information

Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.