FDA recall D-0727-2026

Product

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05

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-0727-2026