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Cleviprex Injectable Emulsion
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DRUG RECALLMODERATE

Cleviprex Injectable Emulsion

Chiesi USA is recalling Cleviprex (clevidipine injectable emulsion) 50 mg/100 mL vials due to a lack of assurance of sterility.

What to do

Healthcare providers should immediately examine their inventory, quarantine any affected product, and contact the manufacturer for return instructions.

Recalled
Listed
Updated
Recall No.
D-0689-2026
Agency
FDA
Firm
Chiesi USA, Inc.
Recall ID
99376
Status
ONGOING

Recall at a glance

Quantity recalled
44280 vials

Why it was recalled

Chiesi USA is recalling Cleviprex (clevidipine injectable emulsion) due to a lack of assurance of sterility. The affected product is supplied in 50 mg/100 mL (0.5 mg/mL) single-use vials.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

CLEVIPREX (clevidipine injectable emulsion)

Lot code
1239521, 1237454, 2027
Strength
50 mg
NDC / UPC
NDC 10122-611-10

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other Sterility Failure recalls

Other recent recalls from Chiesi USA, Inc.

All recalls from Chiesi USA, Inc.

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Editorial summary by Recall Canary · summary updated 2026-07-15 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification