Cary, NC, United States
Chiesi USA, Inc. recalls
4 recalls recorded since 2018, most recently on 19 August 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class III Drugs
- Recall started
- 19 August 2026
- Reason
- Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
- Distribution
- MO, TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0838-2026
- Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01
Ongoing Class II Drugs
- Recall started
- 6 July 2026
- Reason
- Lack of Assurance of Sterility
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0689-2026
- CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.
Ongoing Class II Drugs
- Recall started
- 17 March 2026
- Reason
- Lack of Assurance of Sterility
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0402-2026
- CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Terminated Class II Drugs
- Recall started
- 31 May 2019
- Terminated
- 8 March 2021
- Reason
- Failed Dissolution Specifications: Out of specification result for dissolution.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1342-2019, D-1341-2019
- Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
- ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.