Cleviprex Recalled Due to Lack of Sterility Assurance

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for Cleviprex (clevidipine injectable emulsion), 50 mg/100 mL (0.5 mg/mL). The affected batches include Lots 1239521 and 1237454, which expire October 2027, comprising 44 280 vials.
• The recall was initiated by Chiesi USA, Inc due to a lack of sterility assurance, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Clevidipine is used to treat high blood pressure.

The FDA has issued a Class II recall for Cleviprex (clevidipine injectable emulsion), 50 mg/100 mL (0.5 mg/mL), affecting 44 280 vials. This product is being recalled by Chiesi USA, Inc based in Cary, North Carolina. The recall was initiated on July 6, 2026, and received a Class II classification on July 14, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to a lack of sterility assurance. This deficiency affects Lots 1239521 and 1237454, which will expire in October 2027. Chiesi USA sent out a public notice via letter; no press release has been issued for this recall.

Clevidipine is a prescription medication used to treat hypertension by relaxing blood vessels and increasing the supply of blood and oxygen to the heart. Pharmacists should identify and quarantine Lots 1239521 and 1237454, remove them from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. July 22, 2026. Accessed July 22, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221442