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FDA · Drugs ·

Naropin (ropivacaine hydrochloride Injection recall

Fresenius Kabi USA, LLC recalled Naropin (ropivacaine hydrochloride Injection on July 29, 2026 because of presence of Particulate Matter: Hair was found in products. It was sold nationwide.

Why it was recalled

Presence of Particulate Matter: Hair was found in products

What's recalled

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

Quantity: 92,600 vials

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Fresenius Kabi USA, LLC, Lake Zurich, IL
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Nationwide within in the USA
Status
Ongoing
Recall number
D-0727-2026
Source
U.S. Food and Drug Administration

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