CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0
Lack of Assurance of Sterility
- Agency
- FDA Drug
- Recall date
- Jul 6, 2026
- Status
- Ongoing
- Company
- Chiesi USA, Inc.
1. What product was recalled?
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0
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.
Quantity: 44280 vials
Code or lot text: Lot #: 1239521, 1237454, Exp. Date 10/2027
- LOT
- 1237454
- LOT
- Exp. Date 10/2027
- LOT
- Lot #: 1239521
- NDC
- 10122-610
- NDC
- 10122-610-01
- NDC
- 10122-610-10
- NDC
- 10122-611
- NDC
- 10122-611-01
- NDC
- 10122-611-10
- RECALL-NUMBER
- D-0689-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Lack of Assurance of Sterility
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- unchanged
- created
10. Where is the official source?
Open the official FDA Drug source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.