Class I — UrgentReported 2025-05-14

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)

Recalled by Amneal Pharmaceuticals, LLC

Reason for Recall

Presence of Particulate Matter

Recall Number

D-0402-2025

Classification

Class I

Status

Ongoing

Category

drug

Initiated

2025-04-17

Reported

2025-05-14

Distribution

Nationwide in the US

Code Info

Lot #'s: AL240003, AL240004, Exp.: 01/31/2026

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.