Lidocaine Recall: Spectra Medical Devices 25x5 mL Ampules
Announced 2026-06-10 · FDA
The FDA recall involves Lidocaine HCl Injection USP, 25x5 mL, single-dose ampules, Rx Only, distributed nationwide in the USA by Spectra Medical Devices, LLC. It is due to lack of assurance of sterility and is categorized as moderate severity. Affected lots are AE4013 (exp 1/31/2027), AE5032 & AE5039 (exp 3/31/2028), and AE5104 (exp 8/31/2028); NDC 65282-1605-1.
| Brand | Spectra Medical Devices, Llc |
|---|---|
| Product | 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. |
| Reason | Lack of Assurance of Sterility |
| Severity | moderate |
| Units affected | 210625 |
| Distribution | USA Nationwide |
| Agency | FDA |
| Recall / campaign no. | Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028. |
WHAT YOU SHOULD DO
- Do not use any Lidocaine HCl Injection ampules from the affected lots.
- Contact your healthcare provider or dispensing pharmacy for guidance and potential replacement.
- Return or dispose of affected product according to local regulations or the guidance provided by the dispensing entity.
Other Spectra Medical Devices, Llc recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.