Warning
Spectra Medical Devices Recalls Lidocaine HCl Injection USP
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0554-2026Drug / Pharmaceutical
Spectra Medical Devices Recalls Lidocaine HCl Injection USP
Spectra Medical Devices, Llc · Class II — Moderate Risk
Product Description
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 for Recall
Lack of Assurance of Sterility
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
USA Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Spectra Medical Devices, Llc initiated the recall on May 12, 2026 affecting 210625 ampules. Lack of Assurance of Sterility. The product was distributed in USA Nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Spectra Medical Devices, Llc for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.