Warning
Fresenius Kabi USA Recalls Xylocaine (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-0729-2026Drug / Pharmaceutical
Fresenius Kabi USA Recalls Xylocaine (lidocaine HCl Injection, USP)
Fresenius Kabi USA, LLC · Class II — Moderate Risk
Product Description
Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03
Reason for Recall
Presence of Particulate Matter: Hair was found in products
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
Nationwide within in the USA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a pharmaceutical product from Fresenius Kabi USA, LLC, initiated on July 16, 2026. Presence of Particulate Matter: Hair was found in products. This recall covers 37,250 vials, distributed nationwide. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination and Fresenius Kabi USA recalls.