FDA Drug · D-0689-2026

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.

Class II · Ongoing

Lack of Assurance of Sterility

Affected lots / codes — check yours against thisLot #: 1239521, 1237454, Exp. Date 10/2027

Recalling firm: Chiesi USA, Inc., Cary, NC
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 44280 vials
Distribution: Nationwide within the United States
Recall initiated: July 6, 2026
Classified: July 14, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0689-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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