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High risk Drugs & MedicationsClass II

Spectra Lidocaine HCl Injection Recall

Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Kor

Updated May 12, 2026

Spectra Medical Devices is recalling Lidocaine HCl Injection because the company cannot guarantee the product is sterile. Non-sterile injectable medications can cause serious infection.

Is the Spectra Medical Devices, Llc recalled? Yes. This product was recalled by FDA on May 12, 2026. Details below.

What is recalled

Lidocaine HCl Injection USP, 25x5 mL single-dose ampules (NDC 65282-1605-1), distributed by Spectra Medical Devices LLC, Wilmington, made in South Korea.

Am I affected

You are affected if you have received this medication from a healthcare provider: Lidocaine HCl Injection USP, 25x5 mL ampules with NDC number 65282-1605-1.

What to do right now

Contact your healthcare provider or the hospital/clinic where you received the injection. Do not use any remaining doses. Your provider will advise whether you need monitoring or follow-up care given the sterility concern.

The hazard

Lack of Assurance of Sterility

Brands affected

Spectra Medical Devices, Llc
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0554-2026
Classification
Class II
Recalled
May 12, 2026
Read the official notice

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