Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmin
Summary
The FDA issued a Class II for Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by Spectra Medical Devices, Llc. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0554-2026
Action Date
2026-06-10
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.
Quantity Affected: 210625 ampules
Reason for Recall
Lack of Assurance of Sterility
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-12
Company
Wilmington, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 78 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Spectra Medical Devices, Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Spectra Medical Devices, Llc have FDA actions?
This is the only FDA action we have on record for Spectra Medical Devices, Llc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0554-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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