FDA recall D-0728-2026

Fresenius Kabi USA, LLC · Class II · drug

Product

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

Reason for recall

Presence of Particulate Matter: Hair was found in products

Distribution

Nationwide within in the USA

Key facts

Status: Ongoing
Initiation date: 2026-07-16
Report date: 2026-07-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0728-2026