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High risk Drugs & MedicationsClass II

Naropin Ropivacaine 0.5% Recall

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, Fre

Updated July 16, 2026

Fresenius Kabi is recalling Naropin (ropivacaine hydrochloride injection) 0.5%, 20 mL single-dose vials because hair was found in some products. Use of contaminated injection solution can introduce foreign material into the body, posing a serious risk.

Is the Fresenius Kabi USA, LLC recalled? Yes. This product was recalled by FDA on July 16, 2026. Details below.

What is recalled

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five 20 mL Single-Dose Vials, NDC Tray: 63323-286-23, NDC Vial: 63323-286-05, manufactured by Fresenius Kabi USA, LLC, Lake Zurich, IL.

Am I affected

You are affected if you have Naropin 0.5% single-dose vials with NDC Tray 63323-286-23 or NDC Vial 63323-286-05. Check the label on the vial for these numbers.

What to do right now

Stop using this product immediately. Contact Fresenius Kabi USA, LLC or your healthcare provider with questions about affected vials or the injection you received.

The hazard

Presence of Particulate Matter: Hair was found in products

Brands affected

Fresenius Kabi USA, LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0727-2026
Classification
Class II
Recalled
July 16, 2026
Read the official notice

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