Recall
FDAHealthJuly 6, 2026

Chiesi USA, Inc. — 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, Aust

⚠️ Lack of Assurance of Sterility

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
July 6, 2026

Nationwide within the United States

What's affected?

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.
Lot code
1239521

Additional details

Lot #: 1239521, 1237454, Exp. Date 10/2027

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 44280 vials.

View original FDA notice →

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