OVERLOOKED

Recalls › Medicines & devices

Class IIOngoing

Chiesi USA, Inc. recalls CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0

Recall date · record updated Jul 22, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Chiesi USA, Inc.
Reason
Lack of Assurance of Sterility
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Nationwide within the United States
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99376…

Products

  1. 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.

    Codes/lots: Lot #: 1239521, 1237454, Exp. Date 10/2027Quantity: 44280 vialsRecall no. D-0689-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

More Medicines & devices recalls