Recall: D-0689-2026

Class II - Potentially Harmful

Class IIClassification

2026-07-06Initiated

OngoingStatus

Chiesi USA, Inc.Firm

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

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.