FDA-Drug2026-07-22Class IIPROCESSING DEFECT
Chiesi CLEVIPREX injectable emulsion recalled for lack of sterility assurance
OTHERNationwide distribution
Chiesi CLEVIPREX injection recalled for sterility concerns
Chiesi USA is recalling specific lots of CLEVIPREX (clevidipine) injectable emulsion because the manufacturer cannot guarantee the vials are sterile. This affects vials distributed nationwide with lot numbers 1239521 and 1237454, expiring in October 2027. No injuries have been reported.
- If you have received this medication, contact your pharmacy or healthcare provider immediately.
- Do not use vials from lot #1239521 or #1237454.
- Return affected vials to your pharmacy or healthcare facility.
Hazard
Lack of Assurance of Sterility
Sold states
Nationwide within the United States
Affected count
44280 vials
Manufactured in
175 Regency Woods Pl Ste 600, Cary, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0689-2026Don't want to check this manually?
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