Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US
Summary
The FDA issued a Class III for Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Via by Eugia US LLC. Reason: Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan.
Details
Source
Drug Recall
External ID
D-0552-2026
Action Date
2026-06-10
Status
Ongoing
Category
drug
Product Description
Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02
Lot/Code Info: Lot, expiry: Lot 3LC26029A, exp Feb-2029; Lot 3LC26031A, exp Mar-2029
Quantity Affected: 168,300 vials
Reason for Recall
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-18
Company
East Windsor, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 78 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Eugia US LLC has 17 FDA actions in our database, including 17 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Eugia US LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Eugia US LLC have FDA actions?
Eugia US LLC has 17 FDA actions in our database, including 17 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0552-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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