FDA-Drug2026-07-29Class IIPROCESSING DEFECT
Fresenius Kabi lidocaine injection recalled for hair contamination
What this means
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
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
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 recalls
- FDA-Drug2026-07-29Fresenius Kabi glycopyrrolate 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 Naropin injection recalled for hair contamination
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