FDA
Amneal issues recall for two lots of ropivacaine HCl anesthetic injection
Amneal Pharmaceutical LLC issued a nationwide recall of two lots of Ropivacaine Hydrochloride Injection, USP 500mg/100mL, due to the potential presence of polypropylene fibers from the IV bags. Affected lots are AL240003 and AL240004, both expiring in January 2026. The recall impacts products distributed between April 2024 and November 2024.
Polypropylene particulates in the epidural space or intrathecal administration could lead to severe adverse events, including inflammation, meningitis, hydrocephalus, and potential spinal cord damage. No adverse events have been reported to date.
Source:
(2025, April 18). FDA. Amneal Pharmaceutical LLC Issues a Nationwide Recall of Ropivacaine Hydrochloride Injection, USP 500mg/100mL, Due to the Potential Presence of Particulate Matter. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-ropivacaine-hydrochloride-injection-usp