Reported May 14, 2025 · Ongoing

Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals…

Amneal Pharmaceuticals, LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Amneal Pharmaceuticals, LLC · 400 Crossing Blvd Fl 3 · Bridgewater, NJ · 08807-2863

Is this the product you have?

  • Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL)
  • Manufactured byAmneal Pharmaceuticals Pvt. Ltd., Mehsana, India
  • Distributed byAmneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)
Lot codes and dates
    • Lot #'s: AL240003
    • AL240004
    • Exp.: 01/31/2026
Amount recalled
62 (12x100mL) bags

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

Presence of Particulate Matter

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 6:39 PM UTC

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