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

Recall date

April 17, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0402-2025

FDA classification

Class I

Brand / firm

Amneal Pharmaceuticals, LLC

Sold / distributed

Nationwide in the US

Why it was recalled

Presence of Particulate Matter

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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)