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DRUG RECALLMODERATE
Lidocaine HCl Injection USP
Spectra Medical Devices is recalling Lidocaine HCl Injection USP single-dose ampules due to a lack of assurance of sterility.
What to do
Healthcare providers should immediately stop using the affected product and quarantine any remaining inventory. Contact the distributor for return instructions.
Why it was recalled
Lack of Assurance of Sterility
How to identify it
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.
Official source
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Editorial summary by Recall Canary · last updated 2026-06-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification