Fresenius Kabi Usa, Llc: Naropin (ropivacaine Hydrochloride Injection, Usp), 0.5%, 100 Mg Per

Recall Summary Fresenius Kabi is recalling Naropin (ropivacaine hydrochloride) 0.5% injection in 20 mL vials because hair was found in some products. The affected vials were distributed nationwide across all U.S. states and Washington, D.C. This is a Class II recall, meaning use of the product could cause serious adverse health consequences or death.

Recalling firm

Fresenius Kabi USA, LLC

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

Presence of Particulate Matter: Hair was found in products

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-07-16

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Nationwide within in the USA

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/9f8adae2-be36-4879-8157-318b05a6ab68