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Class II · ModerateActive recall

Xylocaine

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 6133986, Exp. Date 02/2029
Where it was soldNationwide within in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of Particulate Matter: Hair was found in products

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byFresenius Kabi USA, LLC
Brand nameXYLOCAINE
Generic nameLIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE
Active ingredient(s)LIDOCAINE HYDROCHLORIDE ANHYDROUS, EPINEPHRINE BITARTRATE
Distributed by / forFresenius Kabi USA, LLC
Show the full FDA record
Full product labelXylocaine (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 firmFresenius Kabi USA, LLC
DistributionNationwide within in the USA
Quantity37,250 vials
Recall initiated2026-07-16
Report date2026-07-29
Recall completed—
Recall numberD-0729-2026
ClassificationClass II
FDA statusOngoing
Origin on fileLake Zurich IL United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.