FDAFDA recall D-0689-2026 · Jul 22, 2026
Chiesi USA, Inc.: CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0 recall
Recall found
Product
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.
Reason for recall
Lack of Assurance of Sterility
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot #: 1239521, 1237454, Exp. Date 10/2027
- Quantity
- 44280 vials
- Distribution
- Nationwide within the United States
- Recalling firm
- Chiesi USA, Inc., Cary, NC
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-06
Source: openFDA enforcement record D-0689-2026 · search recall number D-0689-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.