Limited official informationFDA Drug Enforcement ReportsRecall date: Jul 22, 2026

CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., C...

Full official product description

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.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

Identifiers to compare

NDC 10122-611-10
Lot 1237454

Affected variants from the official event record
Product or model	Codes and lots	Quantity	Recall number
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 Fr...	Lot #: 1239521, 1237454, Exp. Date 10/2027	44280 vials	D-0689-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Lack of Assurance of Sterility

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

U.S. Food and Drug Administration authoritative

Official scope

Distribution reported by the agency

Nationwide within the United States

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.