FDA-Drug2026-07-29Class IIPROCESSING DEFECT
Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
Nationwide distributionDrugs
What this means
Hair was found in Xylocaine (lidocaine HCl Injection, USP) 1% vials distributed nationwide. The affected product is Lot #6133986 with expiration date 02/2029. No injuries have been reported.
- Check your facility's inventory for Lot #6133986 (expiration 02/2029)
- Do not use affected vials; quarantine and return to Fresenius Kabi
- Contact Fresenius Kabi or the FDA if you have questions
The agency's original wording
Hazard
Presence of Particulate Matter: Hair was found in products
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within in the USA
Affected count
37,250 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0729-2026More Fresenius Kabi recalls
- FDA-Drug2026-07-29Fresenius Kabi glycopyrrolate injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Naropin injection recalled for hair contamination
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