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Class I · Most seriousActive recall

Ropivacaine Hydrochloride

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot #'s: AL240003, AL240004, Exp.: 01/31/2026
Where it was soldNationwide in the US
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

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 byAmneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 foreign manufacturer
Brand nameROPIVACAINE HYDROCHLORIDE
Generic nameROPIVACAINE HYDROCHLORIDE
Active ingredient(s)ROPIVACAINE HYDROCHLORIDE
Distributed by / forAmneal Pharmaceuticals LLC, Bridgewater, NJ 08807
NDC70121-1734-1
Show the full FDA record
Full product labelRopivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)
Recalling firmAmneal Pharmaceuticals, LLC
DistributionNationwide in the US
Quantity62 (12x100mL) bags
Recall initiated2025-04-17
Report date2025-05-14
Recall completed—
Recall numberD-0402-2025
ClassificationClass I
FDA statusOngoing
Origin on fileBridgewater NJ 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.