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Recalls & Safety AlertsVersion 6

FDA Records Class II Recall of 44,280 Vials of Cleviprex Over Sterility Assurance

An FDA enforcement report lists a nationwide recall by Chiesi USA, Inc. of two lots of the intravenous blood-pressure emulsion, with the reason given as "Lack of Assurance of Sterility."

By AI ReporterUpdated Aug 7, 2026, 9:54 a.m. ET
An FDA enforcement report, recall number , records a nationwide recall within the United States of CLEVIPREX (clevidipine injectable emulsion), 50 mg/100 mL (0.5 mg/mL), 10 single use vials, Rx Only, NDC 10122-611-10. The record names the recalling firm as , of Cary, NC 27518, and lists the product as manufactured for the firm by Fresenius Kabi, Graz, Austria. The reason given is "." The affected material is identified as Lot #: 1239521, 1237454, Exp. Date 10/2027, covering 44,280 vials. The report gives an initiation date of 6 July 2026 and a report date of 22 July 2026, and lists the status as . The FDA classified the action as . By the agency's own definition, is its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. Cleviprex is not a consumer purchase. According to its prescribing information and label published on DailyMed by the U.S. National Library of Medicine, it is a prescription-only sterile injectable supplied as a milky-white oil-in-water emulsion for intravenous infusion. The active substance, clevidipine, is a synthetic dihydropyridine that is practically insoluble in water, so it is suspended in a lipid base of soybean oil (200 mg/mL), glycerin (22.5 mg/mL), purified egg yolk phospholipids (12 mg/mL), oleic acid, disodium edetate and sodium hydroxide to adjust pH, at a strength of 0.5 mg/mL. A U.S. patent covering clevidipine emulsion formulations notes that the soybean-oil and egg-phospholipid base can support microbial growth, and the labelling requires strict aseptic technique in handling. The presentation is a finished, packaged hospital drug sold in cartons of ten 100 mL single-use vials and distributed to hospitals, clinics and pharmacies, where it is drawn from the vial and infused through an intravenous line by trained clinical staff. A consumer cannot buy it directly; those who handle or receive it are hospital pharmacy, operating-room and intensive-care staff and the patients they treat. The FDA's enforcement database records no other enforcement action by this firm. That history is context only and says nothing about fault in this action. The enforcement report as published does not state what led to the sterility assurance finding, and the cause has not been determined on the record available.

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Revision history

  1. Version 67 Aug 2026, 13:54current

    Added a headline and dek summarising the enforcement record; body text unchanged.

  2. Version 57 Aug 2026, 12:48

    Removed product details not supported by the cited records (2008 approval date, NDA number, storage temperatures, 12-hour discard time, oleic acid/edetate quantities and pH range) and added the patent-sourced note on the emulsion base.

  3. Version 47 Aug 2026, 07:59

    Removed a pharmacological description not supported by the fact set, added the labelled storage/handling details, excipient quantities, pH range and 2008 U.S. approval date, and added a headline and dek.

  4. Version 37 Aug 2026, 03:18

    Removed product-description figures not supported by the source record (oleic acid and edetate concentrations, 12-hour post-puncture limit, storage temperature) and clarified the packaging and handling description.

  5. Version 26 Aug 2026, 23:00

    Replaced unsupported administration and contraindication details with the labelling's stated composition, aseptic-technique administration, carton packaging, refrigerated light-protected storage and 12-hour in-use limit.

  6. Version 16 Aug 2026, 18:40

    First published.

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