XYLOCAINE
Recalling Firm / Manufacturer: Fresenius Kabi USA, LLC
(Lake Zurich, IL, United States)
FDA Recall Number: D-0728-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
XYLOCAINE
Generic Name
LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
Active Substance(s)
Lidocaine Hydrochloride Anhydrous, Epinephrine Bitartrate
Administration Route
Infiltration
National Drug Code (NDC)
63323-481
Total Quantity Recalled
93,250 vials
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Presence of Particulate Matter: Hair was found in products
Full Product Description
Packaging specifications and labeling details
Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
July 29, 2026
Firm Initiation Date
July 16, 2026
FDA Classification Date
Jul 23, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: 6130235, Exp. Date 02/2027
Distribution Information
Geographic scope of affected shipments
Nationwide within in the USA
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0728-2026
Questo Retrieval Date: September 10, 2026 12:00 1789041611UTCC