Amneal Pharmaceuticals, LLC recalls Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt.
Recalled May 14, 2025 · FDA recall D-0402-2025 · Amneal Pharmaceuticals
Hazard
Presence of Particulate Matter · FDA Class I
Units
62 (12x100mL) bags
Sold at
Nationwide in the US
Description
Presence of Particulate Matter
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)
Manufacturer(s)
Amneal Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →