FDA-Drug2026-07-29Class IIPROCESSING DEFECT
Fresenius Kabi lidocaine injection recalled for hair contamination
OTHERNationwide distribution
Fresenius Kabi lidocaine injection recalled for hair contamination
Hair was found in Fresenius Kabi Lidocaine HCl Injection vials (2%, 20 mg per mL). This affects 181,225 vials nationwide with lot number 6133801 and an expiration date of January 2028. No injuries have been reported.
- Check your pharmacy or facility for vials matching lot #6133801 (expires 01/2028)
- Do not use affected vials
- Contact your supplier or Fresenius Kabi for return or replacement instructions
- Report any use of contaminated vials to your healthcare provider or pharmacist
Hazard
Presence of Particulate Matter: Hair was found in products
Sold states
Nationwide within in the USA
Affected count
181,225 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0726-2026More 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 Xylocaine 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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