American Regent Initiates Class II Recall of Venofer (Iron Sucrose) Injection Over Glass Delamination Risk
American Regent, Inc. has initiated a Class II recall for Venofer (iron sucrose) Injection due to potential glass delamination, leading to particulate matter. This event, D-0080-2025, impacts nationwide supply in the USA, demanding immediate attention from procurement, regulatory, and supply chain leaders to assess inventory, patient safety, and future supply resilience for critical parenteral iron therapies.
FDA Class II Recall: Venofer (Iron Sucrose) Injection Due to Glass Delamination
American Regent, Inc. has initiated a voluntary Class II recall for its Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials. This recall, identified as D-0080-2025, commenced on November 11, 2024, and is currently ongoing. The primary concern stems from the potential presence of particulate matter resulting from glass delamination within the vials. For procurement directors and supply chain VPs, this event necessitates an immediate and thorough review of existing inventory, specifically for affected Lot# 4196 with an expiration date of May 31, 2026. The potential for glass delamination directly impacts product quality and patient safety, as intravenous administration of particulate matter can lead to serious adverse health consequences, including emboli, phlebitis, and granuloma formation. Regulatory affairs heads must ensure their organizations are fully compliant with recall procedures, including quarantine and return of affected product, and prepare for potential increased scrutiny on container-closure integrity for all sterile injectable products within their portfolios. This incident underscores the critical importance of robust quality control throughout the manufacturing and packaging process, extending to the materials used for primary containers.
American Regent's Venofer: Market Position and Supply Chain Vulnerabilities
American Regent, Inc., with an address at 5 Ramsey Rd, Shirley, NY 11967-4701, is the firm initiating this recall. The recalled product, Venofer (iron sucrose) Injection, USP, is a human prescription drug approved under NDA021135, intended for intravenous use as a parenteral iron replacement therapy. Fresenius Medical Care Holdings, Inc. is also identified as a distributor of this product. Given its nationwide distribution pattern across the USA, this recall has broad implications for healthcare providers and patients relying on this critical medication. For business development executives, this event highlights potential market gaps and opportunities for alternative iron sucrose suppliers or similar parenteral iron therapies. Supply chain VPs must evaluate their current sourcing strategies for such essential injectables, considering the inherent vulnerabilities exposed by packaging material defects. The incident reinforces the need for rigorous supplier qualification processes that extend beyond the active pharmaceutical ingredient (API) manufacturer to include all critical components, such as glass vials, to ensure product integrity and uninterrupted supply.
Navigating Regulatory Scrutiny and Future Compliance for Injectables
The FDA's classification of this as a Class II recall indicates that exposure to the particulate matter could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. However, the ongoing status of recall D-0080-2025 means American Regent, Inc. is actively working to remove the affected product from the market and is expected to address the root cause of the glass delamination. This situation serves as a critical reminder for all pharmaceutical manufacturers of sterile injectables regarding the stringent quality requirements for both drug substances and primary packaging materials. Regulatory affairs teams should anticipate heightened FDA focus on container-closure systems, particulate matter testing, and overall quality management systems across the industry. Procurement teams must integrate comprehensive packaging material quality assessments and supplier audit findings more deeply into their risk management frameworks. This incident reinforces the necessity for proactive quality assurance measures that encompass all aspects of drug product manufacturing, from raw materials to final packaging, to safeguard patient safety and ensure continuous product availability.