Fresenius Kabi USA, LLC Lidocaine HCl Injection, USP Recall (January 2028)
Announced 2026-07-29 · FDA
Fresenius Kabi USA, LLC is recalling Lidocaine HCl Injection, USP 2%, 5 mL single-dose vials (Rx only) due to the presence of hair particulate matter. The recall covers 181,225 vials distributed nationwide in the United States (Lot 6133801; Exp. Date 01/2028) and is overseen by the FDA.
| Brand | Fresenius Kabi USA, LLC |
|---|---|
| Product | 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 |
| Reason | Presence of Particulate Matter: Hair was found in products |
| Severity | moderate |
| Units affected | 92600 |
| Distribution | Nationwide within in the USA |
| Agency | FDA |
| Recall / campaign no. | Lot #: 6133801, Exp. Date 01/2028 |
WHAT YOU SHOULD DO
- Do not use any Lidocaine HCl Injection, USP vials from Lot 6133801 with Exp. Date 01/2028.
- Contact your pharmacy or healthcare provider to arrange a replacement and obtain return instructions.
- If you have used the product, seek medical advice if you have concerns and report any adverse experiences to the FDA.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.