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Class II · ModerateActive recall

Naropin

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 6133436, Exp. Date 10/2028
Where it was soldNationwide within in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of Particulate Matter: Hair was found in products

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byFresenius Kabi USA, LLC
Brand nameNAROPIN
Generic nameROPIVACAINE HYDROCHLORIDE
Active ingredient(s)ROPIVACAINE HYDROCHLORIDE
Distributed by / forFresenius Kabi USA, LLC
Show the full FDA record
Full product labelNaropin (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
Recalling firmFresenius Kabi USA, LLC
DistributionNationwide within in the USA
Quantity92,600 vials
Recall initiated2026-07-16
Report date2026-07-29
Recall completed—
Recall numberD-0727-2026
ClassificationClass II
FDA statusOngoing
Origin on fileLake Zurich IL United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.