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Class II · ModerateActive recall

Cleviprex

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 1239521, 1237454, Exp. Date 10/2027
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of Assurance of Sterility

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byChiesi USA, Inc.
Brand nameCLEVIPREX
Generic nameCLEVIPIDINE
Active ingredient(s)CLEVIDIPINE
Distributed by / forChiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria
NDC10122-611-10
Show the full FDA record
Full product labelCLEVIPREX (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.
Recalling firmChiesi USA, Inc.
DistributionNationwide within the United States
Quantity44280 vials
Recall initiated2026-07-06
Report date2026-07-22
Recall completed—
Recall numberD-0689-2026
ClassificationClass II
FDA statusOngoing
Origin on fileCary NC United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.