Chiesi USA, Inc. recalls CLEVIPREX
- Recalling company
- Chiesi USA, Inc.
- 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
- Lack of Assurance of Sterility
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 6, 2026
- Reported
- Jul 22, 2026
- Distribution
- Nationwide within the United States
- Status
- Ongoing
- Quantity
- 44280 vials
- Lot / codes
- Lot #: 1239521, 1237454, Exp. Date 10/2027
- Company location
- Cary, NC
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0689-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0689-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.