FDA-Drug2026-07-29Class IIPROCESSING DEFECT
Fresenius Kabi Naropin injection recalled for hair contamination
Nationwide distributionDrugs
What this means
Hair was found in Naropin (ropivacaine hydrochloride) injection vials used for local anesthesia. The affected product is the 0.5% concentration in 20 mL single-dose vials. Approximately 92,600 vials from Lot #6133436 (expiration 10/2028) were distributed nationwide.
- If you have Naropin from the affected lot, do not use it.
- Contact Fresenius Kabi or your healthcare provider with questions about replacement or alternatives.
- Healthcare facilities should quarantine and return affected vials to the manufacturer.
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
92,600 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0727-2026More 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 lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
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