Lidocaine HCl Injection USP
Spectra Medical Devices is recalling Lidocaine HCl Injection USP single-dose ampules due to a lack of assurance of sterility.
Healthcare providers should immediately stop using the affected product and quarantine any remaining inventory. Contact the distributor for return instructions.
Why it was recalled
Spectra Medical Devices is recalling Lidocaine HCl Injection USP single-dose ampules due to a lack of assurance of sterility. The use of non-sterile injectable products can lead to serious infections or adverse health consequences.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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.
- Recall #
- D-0554-2026
Where it was sold
Distributed nationwide.
Official source
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