Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only

Spectra Medical Devices, Llc has recalled Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on June 10, 2026 and was initiated on May 12, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, with approximately 210625 ampules affected. The company behind the recall is Spectra Medical Devices, Llc, based in Wilmington, MA. The FDA describes the product as: “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.”

Why was Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only recalled?

According to the FDA, the stated reason for the recall is: “Lack of Assurance of Sterility.” In plain terms, this recall relates to a sterility or contamination concern.

Sterile medicines, such as injectables and eye drops, must be completely free of microorganisms and stray particles. This recall means that sterility could not be assured or that contamination was found or suspected. Using a non-sterile product of this kind can cause infections, which is why these recalls are treated seriously.

What should you do?

If you think you may have bought Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, compare it against the product description and identifying codes (Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Spectra Medical Devices, Llc or your local health authority.

About this recall

This recall was distributed in MA. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.