Recall: D-0727-2026

Class II - Potentially Harmful

Class IIClassification

2026-07-16Initiated

OngoingStatus

Fresenius Kabi USA, LLCFirm

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

Distribution

Nationwide within in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.