FDA recall D-0726-2026

Fresenius Kabi USA, LLC · Class II · drug

Product

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

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-0726-2026