Spectra Medical Devices, Llc: Lidocaine Hcl Injection Usp, 25x5 Ml, Single-dose Ampules

Recall Summary Spectra Medical Devices is recalling Lidocaine HCl Injection USP (25x5 mL ampules, NDC 65282-1605-1) distributed nationwide because the company cannot guarantee the product is sterile. This is a Class II recall, meaning use could cause serious adverse health effects. The affected product was made in South Korea and distributed across all U.S. states and Washington, D.C.

Recalling firm

Spectra Medical Devices, Llc

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

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-05-12

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

USA Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/ea062aed-df56-445d-a58e-605056479e65