FDA-Drug2026-07-29Class IIPROCESSING DEFECT
Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
Nationwide distribution
Fresenius Kabi Xylocaine recalled for particulate matter contamination
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
Hazard
Presence of Particulate Matter: Hair was found in products
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 USA, LLC recalls
- FDA-Drug2026-07-29Fresenius Kabi Naropin injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi glycopyrrolate injection recalled for hair contamination
- FDA-Drug2026-06-17Fresenius Kabi epinephrine injection recalled for failed impurity specifications
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