Chiesi USA, Inc.
Chiesi USA, Inc. appears in FDA public data with 4 recalls, 0 510(k) clearances, 8 FDA inspections, and 3 compliance actions on record. Its most recent recall (D-0689-2026, Class II) was initiated on July 6, 2026.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 0
- Inspections
- 8
- Compliance Actions
- 3
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0689-2026 | Class II | CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, | July 6, 2026 |
| D-0402-2026 | Class II | CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi US | March 17, 2026 |
| D-1342-2019 | Class II | Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Labora | May 31, 2019 |
| D-1341-2019 | Class II | ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chi | May 31, 2019 |