Reported Jun 10, 2026 · Ongoing
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC,…
Spectra Medical Devices, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spectra Medical Devices, Llc · 299 Ballardvale St · Wilmington, MA · 01887-1066
Is this the product you have?
- Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only
- Distributed bySpectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1
- Lot codes and dates
Lot#: AE4013Exp 1/31/2027AE5032 & AE5039Exp 3/31/2028AE5104Exp 8/31/2028
- Amount recalled
- 210625 ampules
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
This product could cause temporary or reversible health problems — stop using it.
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