Class IOngoing

Ropivacaine Hydrochloride Injection recall

FDA recall D-0402-2025 · initiated Apr 17, 2025

Most serious — a reasonable probability that use will cause serious harm or death.

Why it was recalled

Presence of Particulate Matter

Details

Product: Ropivacaine 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 company: Amneal
Classification: Class I
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the US
Initiated: Apr 17, 2025
FDA report date: May 14, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0402-2025 ↗

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