Spectra Medical Devices, Llc: Lidocaine Hcl Injection Usp, 25x5 Ml, Single-dose Ampules
Recall Summary Spectra Medical Devices is recalling Lidocaine HCl Injection USP (25x5 mL single-dose ampules, NDC 65282-1605-1) distributed nationwide because the company cannot guarantee the product is sterile. Lidocaine is a local anesthetic medication used by healthcare providers. This is a Class II recall, meaning use of the product could cause serious adverse health effects.
- Recalling firm
- 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
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-12
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- USA Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/4b01fe55-89f9-4830-92a2-3877a6943f60