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CLASS II · ModerateFDA

Fresenius Kabi USA, LLC recalls Xylocaine

📅 Jul 16, 2026 · 📍 Nationwide
Recalling company
Fresenius Kabi USA, LLC
Product
Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01
Reason
Presence of Particulate Matter: Hair was found in products
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jul 16, 2026
Reported
Jul 29, 2026
Distribution
Nationwide within in the USA
Status
Ongoing
Quantity
93,250 vials
Lot / codes
Lot #: 6130235, Exp. Date 02/2027
Company location
Lake Zurich, IL
Recall type
Voluntary: Firm initiated
Recall number
D-0728-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0728-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.