Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile
Summary
The FDA issued a Class II for Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose by Fresenius Kabi USA, LLC. Reason: Presence of Particulate Matter: Hair was found in products.
Details
Source
Drug Recall
External ID
D-0726-2026
Action Date
2026-07-29
Status
Ongoing
Category
drug
Product Description
Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01
Lot/Code Info: Lot #: 6133801, Exp. Date 01/2028
Quantity Affected: 181,225 vials
Reason for Recall
Presence of Particulate Matter: Hair was found in products
Distribution
Nationwide within in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-16
Company
Lake Zurich, IL
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 43 drug recalls issued in the same week, part of 88 drug-related FDA actions this month.
Fresenius Kabi USA, LLC has 50 FDA actions in our database, including 50 recalls.
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 (Fresenius Kabi USA, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Kabi USA, LLC have FDA actions?
Fresenius Kabi USA, LLC has 50 FDA actions in our database, including 50 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0726-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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