Chiesi USA, Inc. recalls
Every recall we track for Chiesi USA, Inc. — 5 in all, from 2019–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
5 recalls since 2017.
All FDA recall records for Chiesi USA, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 1 | 1 | 2 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 1 | 2 | 3 |
Most common reasons for Chiesi USA, Inc. recalls
What to do if you have a recalled Chiesi USA, Inc. product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All Chiesi USA, Inc. recalls
4 shown- Lower riskDrug
Chiesi USA, Inc. recalls Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only,
Chiesi USA recalls Revcovi injection due to stability issues. The product may not maintain proper protein concentration. Affected units have specific lot numbers and expiration dates.
ChiesiAug 19, 2026 - UnratedDrug
Chiesi USA, Inc. recalls CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for:
Chiesi USA recalls 10-vial CLEVIPREX injectable emulsion due to lack of sterility assurance. Patients should not use affected lots with NDC 10122-611-10.
ChiesiJul 6, 2026 - UnratedDrug
Chiesi USA, Inc. recalls CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC
Chiesi USA recalls CUROSURF 240mg intratracheal suspension vials due to lack of sterility assurance. Affected lots expire 09/2026 and 10/2026. Contact for remedy details.
ChiesiMar 17, 2026 - Lower riskDrug
Chiesi USA, Inc. recalls Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH
Chiesi USA recalls 600mg Zileuton Extended-Release Tablets due to failed dissolution testing. This may affect medication effectiveness. Contact your doctor for guidance.
ChiesiMay 31, 2019
Chiesi USA, Inc. recall questions
How many recalls has Chiesi USA, Inc. had?
5 recalls from Chiesi USA, Inc. are on record with U.S. safety agencies, from 2019–2026.
What is the most recent Chiesi USA, Inc. recall?
Chiesi USA, Inc. recalls Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only,, dated Aug 19, 2026. Every Chiesi USA, Inc. recall is listed on this page, newest first.
Why are Chiesi USA, Inc. products recalled?
The most common reasons on record: Failed Dissolution Specifications: Out of specification result for dissolution. (2); Lack of Assurance of Sterility (2).
What should I do if I have a recalled Chiesi USA, Inc. product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new Chiesi USA, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.