Chiesi CLEVIPREX 50mg/100mL injectable vials: Risk of contamination
Chiesi USA recalls 10-vial CLEVIPREX injectable emulsion due to lack of sterility assurance. Patients should not use affected lots with NDC 10122-611-10.
“Chiesi CLEVIPREX 50mg/100mL injectable vials: Risk of contamination.” GovInfoNow, updated August 7, 2026. https://govinfonow.com/recall/31171-chiesi-cleviprex-50mg-100ml-injectable-vials-risk-of-contamination. Based on FDA recall #D-0689-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0689-2026%22&limit=1).
Chiesi USA, Inc. recalled CLEVIPREX (clevidipine injectable emulsion) due to a lack of assurance of sterility, the FDA said on July 6, 2026.
How to tell if you have it
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials
NDC 10122-611-10
Lot #: 1239521, 1237454
Exp. Date 10/2027
The hazard
The recall addresses a lack of assurance of sterility in the product.
Context
GovInfoNow's records show Chiesi USA, Inc. has issued three other recalls since May 31, 2019. Other recent recalls include the Chiesi Revcovi Injection Recall on Aug. 19, 2026, and the Chies: CUROSURF 240mg Vial Recall on March 17, 2026. Similar product recalls in the sector include the Fresenius Kabi 5% Dextrose Injection Recall on March 11, 2026, and the Cipla Lanreotide Injection Recall on March 13, 2026.
How to tell if you have this one
Check for the NDC code 10122-611-10 on the vial label. The product was manufactured by Fresenius Kabi in Austria and expires October 2027.
Brand
Chiesi
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop Using Now
Discard the vial immediately if it has the NDC 10122-611-10 and lot numbers 1239521 or 1237454.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 16 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0689-2026 (July 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0689-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.