Home / Recalls / Fresenius Kabi USA, LLC / D-0728-2026

D-0728-2026 Class II Ongoing

Recalled by Fresenius Kabi USA, LLC — Lake Zurich, IL

FDA drug recall D-0728-2026 was initiated by Fresenius Kabi USA, LLC on July 16, 2026 and is designated Class II. Reason for recall: Presence of Particulate Matter: Hair was found in products The recall status is ongoing. Affected quantity: 93,250 vials.

Recall Details

Product Type: Drugs
Report Date: July 29, 2026
Initiation Date: July 16, 2026
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 93,250 vials

Product Description

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 for Recall

Presence of Particulate Matter: Hair was found in products

Distribution Pattern

Nationwide within in the USA

Code Information

Lot #: 6130235, Exp. Date 02/2027

Other recalls by Fresenius Kabi USA, LLC

D-0725-2026 Class II — Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in (July 16, 2026)
D-0729-2026 Class II — Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 2 (July 16, 2026)
D-0727-2026 Class II — Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg (July 16, 2026)
D-0726-2026 Class II — Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose (July 16, 2026)
D-0581-2026 Class III — Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Ka (May 14, 2026)
Z-2224-2026 Class I — Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 (May 6, 2026)
Z-2223-2026 Class I — LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. (May 6, 2026)
D-0436-2026 Class II — 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL free (March 11, 2026)
D-0427-2026 Class II — 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL (March 11, 2026)
D-0425-2026 Class II — 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, (March 11, 2026)