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High risk Drugs & MedicationsClass II

CLEVIPREX Clevidipine Recall

CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary

Updated July 6, 2026

Chiesi USA is recalling CLEVIPREX (clevidipine) injectable emulsion vials because the manufacturer cannot assure the product remains sterile. This injectable drug is used to manage blood pressure; a non-sterile product could cause serious infection.

Is the Chiesi USA, Inc. recalled? Yes. This product was recalled by FDA on July 6, 2026. Details below.

What is recalled

CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), in packages of 10 Single Use Vials, NDC 10122-611-10, manufactured by Fresenius Kabi in Graz, Austria for Chiesi USA, Inc., Cary, North Carolina.

Am I affected

You are affected if you have been prescribed or dispensed CLEVIPREX vials with NDC number 10122-611-10. Check your prescription label and vial packaging for this NDC number.

What to do right now

Contact your healthcare provider or pharmacist immediately if you have received CLEVIPREX vials with NDC 10122-611-10. Do not use the product. Your provider will advise on next steps, including whether you need an alternative blood pressure medication.

The hazard

Lack of Assurance of Sterility

Brands affected

Chiesi USA, Inc.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0689-2026
Classification
Class II
Recalled
July 6, 2026
Read the official notice

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