The Recall Desk
SevereFDA (Drugs)·D-0689-2026·Announced 2026-07-22

Cleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns

Chiesi USA, Inc. is recalling Cleviprex (clevidipine) injectable emulsion due to lack of assurance of sterility. The affected product is distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall for a sterility defect in an intravenous drug product. Lack of sterility assurance in injectable medications poses a potential for serious health consequences including infection and sepsis, meeting the Severe threshold even without reported illnesses.

Plain-English summary

Chiesi USA, Inc. is recalling Cleviprex (clevidipine) injectable emulsion 50 mg/100 mL (0.5 mg/mL) because the manufacturer cannot assure the product's sterility.

The affected product is Cleviprex Lot #1239521 and Lot #1237454 with expiration date 10/2027. This is a prescription-only intravenous medication manufactured for Chiesi USA, Inc. by Fresenius Kabi in Graz, Austria. The product has been distributed nationwide within the United States.

Patients who have this medication should contact their healthcare provider for guidance. Healthcare providers should not dispense the affected lots and should quarantine any remaining stock.

The recalled product

Product
CLEVIPREX (CLEVIPIDINE)
Brand
CLEVIPREX
Manufacturer
Chiesi USA, Inc.
Category
Drug — Injectable / Intravenous
Hazard
  • lack-of-sterility
  • injectable-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category