FDAClass IIJuly 22, 2026

Cleviprex recall: Sterility Concern

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…

Why was Cleviprex recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Chiesi USA, Inc.
Quantity
44280 vials
Distribution
Nationwide within the United States
Recall date
July 22, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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