United StatesFresenius Kabi is recalling several injectable products sold nationwide, including Glycopyrrolate Injection 0.2 mg/mL 25×5 mL vials, Lidocaine HCl Injection 2% 5 mL vials, Naropin (ropivacaine) 0.5% 20 mL vials, and Xylocaine (lidocaine) 1% 20 mL and 50 mL vials — see NDCs and lot numbers 6134349/6134620 (exp 11/2026); 6133801 (exp 01/2028); 6133436 (exp 10/2028); 6130235 (exp 02/2027); 6133986 (exp 02/2029) for affected units. The products were recalled because hair/particulate matter was found in the vials; the recall is ongoing nationwide.
What's being recalled
Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07
Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01
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
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
Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03
Recalling firm: Fresenius Kabi USA, LLC, Lake Zurich, IL, United States.
How to identify it
Lot #: 6134349, 6134620 Exp. Date 11/2026 Lot #: 6133801, Exp. Date 01/2028 Lot #: 6133436, Exp. Date 10/2028 Lot #: 6130235, Exp. Date 02/2027 Lot #: 6133986, Exp. Date 02/2029
The hazard
Presence of Particulate Matter: Hair was found in product
Presence of Particulate Matter: Hair was found in products
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)