Amneal FDA warning highlights use of contaminated bags in sterile injectable drugs, impacting quality control.
• FDA issues warning to Amneal on August 27, 2025.
• Contaminated bags used for ropivacaine hydrochloride in India.
• Quality control failures impact drug safety and compliance.
The U.S. Food and Drug Administration (FDA) issued a warning to Amneal Pharmaceuticals on August 27, 2025, for using contaminated bags in a sterile injectable drug. The issue was identified during a March inspection at an Amneal facility in India. Inspectors found white polypropylene fibers in bags used for ropivacaine hydrochloride, an epidural injectable. Read more on STAT+.
Moreover, the FDA noted that Amneal minimized the severity of the contamination risk. The company was aware of the issue for over a year before conducting an internal investigation in 2024. Several batches were rejected after investigations in late 2022 and early 2023.
Why it matters
This warning underscores significant quality control failures at Amneal, a major supplier of generic and specialty medicines. The use of contaminated bags poses risks to patient safety and highlights lapses in compliance with regulatory standards.
What’s next
Amneal is expected to address these quality control issues promptly to comply with FDA standards. The company must ensure that all future batches meet safety requirements. For further insights, visit our Regulatory & Approvals section.