CLEVIPREX — Class II drug recall D-0689-2026
Ongoing recall by Chiesi USA, Inc., reported 2026-07-22, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0689-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Chiesi USA, Inc., Cary, NC, United States |
| Recall initiated | 2026-07-06 |
| Classified | 2026-07-14 |
| Reported by FDA | 2026-07-22 |
| Distributed | Nationwide (US) |
| Quantity | 44,280 vials |
| Reason classes | sterility |
| NDC | 10122-0610, 10122-0610-01, 10122-0610-10, 10122-0611, 10122-0611-01, 10122-0611-10 |
| Lot numbers | 1237454, 1239521 |
| Expiration dates | 2027-10 |
Product
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.
Reason for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0689-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.