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FDA · Drugs ·

CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL) recall

Chiesi USA, Inc. recalled CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL) on July 22, 2026 because of lack of Assurance of Sterility. It was sold nationwide.

Why it was recalled

Lack of Assurance of Sterility

What's recalled

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.

Quantity: 44280 vials

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Chiesi USA, Inc., Cary, NC
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Nationwide within the United States
Status
Ongoing
Recall number
D-0689-2026
Source
U.S. Food and Drug Administration

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