Home/Recalls/FDA-D-0729-2026
FDA DrugsClass II

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

Published: July 29, 2026Recall ID: D-0729-2026Category: drugsCountry: US
US
PharmaceuticalFDA DrugsUSUS

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

Reason for Recall / Hazard

Presence of Particulate Matter: Hair was found in products

Product Description & Identification

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

Affected Products

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

Additional Source Details

FieldValue
CityLake Zurich
StateIL
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Openfda › Spl idea480a68-5927-4278-9deb-2956961da428
Openfda › Brand nameXYLOCAINE
Openfda › Spl set idba082c2f-64f4-419d-9c88-74f203316e17
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Openfda › Generic nameLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
Openfda › Product typeHUMAN PRESCRIPTION DRUG
Openfda › Substance name › 1LIDOCAINE HYDROCHLORIDE ANHYDROUS
Openfda › Substance name › 2EPINEPHRINE BITARTRATE
Openfda › Manufacturer nameFresenius Kabi USA, LLC
Openfda › Application numberNDA006488
Openfda › Is original packagertrue
Event id99449
Address 13 Corporate Dr
Address 2N/A
Code infoLot #: 6133986, Exp. Date 02/2029
Postal code60047-8930
Report date20260729
Product typeDrugs
Product quantity37,250 vials
Reason for recallPresence of Particulate Matter: Hair was found in products
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260716
Initial firm notificationLetter
Center classification date20260723

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Overview

  • Recalling FirmFresenius Kabi USA, LLC
  • StatusOngoing
  • Risk LevelClass II
  • DistributionNationwide within in the USA
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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🚨 SAFETY ALERT: Fresenius Kabi USA, LLC - 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

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https://therecallfile.com/recalls/xylocaine-lidocaine-hcl-injection-usp-1-500-mg-per-50-ml-10-mg-per-ml/FDA-D-0729-2026
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Spread the WordXylocaine (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

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