FDA Drug · D-0554-2026

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.

Class II · Ongoing

Lack of Assurance of Sterility

Affected lots / codes — check yours against thisLot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.

Recalling firm: Spectra Medical Devices, Llc, Wilmington, MA
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 210625 ampules
Distribution: USA Nationwide
Recall initiated: May 12, 2026
Classified: June 2, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0554-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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