FDA · Drugs ·
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules recall
Spectra Medical Devices, Llc recalled Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules on June 10, 2026 because of lack of Assurance of Sterility. It was sold nationwide.
Why it was recalled
Lack of Assurance of Sterility
What's recalled
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.
Quantity: 210625 ampules
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Spectra Medical Devices, Llc, Wilmington, MA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
USA Nationwide - Status
- Ongoing
- Recall number
- D-0554-2026
- Source
- U.S. Food and Drug Administration
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