Class II

Drug Recall: 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.

Spectra Medical Devices, Llc · May 12, 2026

Reason for Recall

Lack of Assurance of Sterility

Distribution

USA Nationwide

States Affected

NATIONWIDE

Quantity Affected

210625 ampules

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0554-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.