Notice names this product. Chiesi USA’s CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0 is named in FDA Class II recall D-0689-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Lack of Assurance of Sterility Identifying details: Lot #: 1239521, 1237454, Exp. Date 10/2027. Units affected: 44280 vials. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Lack of Assurance of Sterility
Company / brand: Chiesi USA
Affected product: CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0
Official ID D-0689-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.