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.
Recall at a glance
- Quantity recalled
- 210625 ampules
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
- Lot code
- AE4013, 2027
- NDC / UPC
- NDC 65282-1605-1
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Spectra Medical Devices, Llc
Editorial summary by Recall Canary · summary updated 2026-06-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification