Home/Browse All/FDA-D-0728-2026
FDA DrugsClass II

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

Published: July 29, 2026Recall ID: D-0728-2026Category: Drugs & MedicineCountry: United States
US
PharmaceuticalFDA DrugsUSUS

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

Recalling Firm: Fresenius Kabi USA, LLC

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Translate NoticeTranslate notice text, hazard warnings, and descriptions into any supported language.

Reason for Recall / Hazard

Presence of Particulate Matter: Hair was found in products

Product Description & Identification

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

Affected Products

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

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 #: 6130235, Exp. Date 02/2027
Postal code60047-8930
Report date20260729
Product typeDrugs
Product quantity93,250 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

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only...?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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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%, 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

Check if your household is affected:
https://therecallfile.com/recalls/xylocaine-lidocaine-hcl-injection-usp-1-200-mg-per-20-ml-10-mg-per-ml/FDA-D-0728-2026
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Spread the WordXylocaine (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

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