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Drug FDA Class II Ongoing Contamination / non-sterility

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.

Spectra Medical Devices, Llc Published Jun 10, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Spectra Medical Devices, Llc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility

Hazards

Lack of Assurance of Sterility · primary

Affected products (1)

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.

LIDOCAINE HYDROCHLORIDE · 210625 ampules

NDC: 65282-1605, 65282-1605-1
Code info: Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.

Affected areas

Nationwide

Timeline

  1. Initiated
    May 12, 2026
  2. Published
    Jun 10, 2026
Recall number
D-0554-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.