Chiesi recalls
FDA enforcement reports naming Chiesi USA, Inc. as the recalling firm.
- Recall reports
- 5
- Class I (serious)
- 0
- Most recent report
- Sep 9, 2026
- Sep 9, 2026Revcovi (elapegademase-lvlr) Injection, 2Drug · Chiesi USA, Inc.Failed Stability Specifications: Out of specification stability result for the protein concentration profile.Class III
- Jul 22, 2026CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0Drug · Chiesi USA, Inc.Lack of Assurance of SterilityClass II
- Apr 1, 2026CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx on…Drug · Chiesi USA, Inc.Lack of Assurance of SterilityClass II
- Jun 19, 2019ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distr…Drug · Chiesi USA, Inc.Failed Dissolution Specifications: Out of specification result for dissolution.Class II
- Jun 19, 2019Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by:…Drug · Chiesi USA, Inc.Failed Dissolution Specifications: Out of specification result for dissolution.Class II