Spectra Lidocaine HCl Injection Recall
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Kor
Updated May 12, 2026
Spectra Medical Devices is recalling Lidocaine HCl Injection because the company cannot guarantee the product is sterile. Non-sterile injectable medications can cause serious infection.
Is the Spectra Medical Devices, Llc recalled? Yes. This product was recalled by FDA on May 12, 2026. Details below.
What is recalled
Lidocaine HCl Injection USP, 25x5 mL single-dose ampules (NDC 65282-1605-1), distributed by Spectra Medical Devices LLC, Wilmington, made in South Korea.
Am I affected
You are affected if you have received this medication from a healthcare provider: Lidocaine HCl Injection USP, 25x5 mL ampules with NDC number 65282-1605-1.
What to do right now
Contact your healthcare provider or the hospital/clinic where you received the injection. Do not use any remaining doses. Your provider will advise whether you need monitoring or follow-up care given the sterility concern.
The hazard
Lack of Assurance of Sterility
Brands affected
- Source
- FDA
- Category
- Drugs & Medications
- Recall ID
- fda-D-0554-2026
- Classification
- Class II
- Recalled
- May 12, 2026
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