Recall: D-0554-2026

Class II - Potentially Harmful

Class IIClassification

2026-05-12Initiated

OngoingStatus

Spectra Medical Devices, LlcFirm

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

Lack of Assurance of Sterility

Distribution

USA Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.