CLASS II ONGOING Drug recall · Reported 22 Jul 2026 · FDA Enforcement Report
Cleviprex (clevidipine injectable emulsion) 50 mg recalled by Chiesi USA
Chiesi USA is recalling Cleviprex (clevidipine injectable emulsion) 50 mg/ (0.5 mg/mL) Use Vials, distributed nationwide in the US. The recall was initiated on 6 Jul 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0689-2026
- FDA event ID
- 99376
- Recalling firm
- Chiesi USA, Cary, NC
- Brand
- Cleviprex
- Manufacturer
- Chiesi USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Jul 2026
- FDA classified
- 14 Jul 2026
- Reported
- 22 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Jul 2026 | Recall initiated by company | |
| 14 Jul 2026 | Classified by FDA | +8 days |
| 22 Jul 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: 1239521, 1237454, Exp. Date 10/2027
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Chiesi USA
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Revcovi (elapegademase-lvlr) Injection, 2.4mg/ (1.6 mg/mL) recalledRevcovi | Chiesi USA | Potency & Assay | MO, TN |
| Drug | CLASS II | Curosurf (poractant alfa), 240 mg recalled by Chiesi USACurosurf | Chiesi USA | Sterility | Nationwide |
| Drug | CLASS II | Zyflo CR (zileuton) extended-release tablets, 600 mg recalled | Chiesi USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Zileuton Extended-Release Tablets, 600 mg recalled by Chiesi USA | Chiesi USA | Potency & Assay | Nationwide |