Moderate riskFDA DrugJul 29, 2026Class II

Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination

Hair was found in Xylocaine (lidocaine HCl Injection, USP) 1% vials distributed nationwide. The affected product is Lot #6133986 with expiration date 02/2029. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Fresenius Kabi recalls

What to do

Check your facility's inventory for Lot #6133986 (expiration 02/2029)
Do not use affected vials; quarantine and return to Fresenius Kabi
Contact Fresenius Kabi or the FDA if you have questions

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: 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
Sold in: Nationwide
Made for: All ages (0 months and older)

This recall covers 5 products — see all of them.

Details

Units affected: 37,250 vials
Illnesses reported: None reported
Manufactured in: 3 Corporate Dr, N/A, Lake Zurich, IL, United States
Classification: Class II
Recall number: D-0729-2026

In the FDA's words

Description: 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 Presence of Particulate Matter: Hair was found in products Lot #: 6133986, Exp. Date 02/2029 Distribution: Nationwide within in the USA Affected quantity: 37,250 vials
Hazard: Presence of Particulate Matter: Hair was found in products

5 products in this recall

Fresenius Kabi Xylocaine, Naropin and more recalled over hair

Fresenius Kabi is recalling five injectable medicine products because hair was found in some vials. The products are Xylocaine (two sizes), Naropin, lidocaine HCl injection and glycopyrrolate injection, all made by Fresenius Kabi in Lake Zurich, Illinois, and sold nationwide. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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…
D-0725-2026 · 59,425 vials
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 600…
D-0726-2026 · 181,225 vials
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…
D-0727-2026 · 92,600 vials
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,…
D-0728-2026 · 93,250 vials
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,… (this page)
D-0729-2026 · 37,250 vials