Why it was recalled
Lack of Assurance of Sterility
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 1239521, 1237454, Exp. Date 10/2027
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0689-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 6, 2026
- FDA report date
- Jul 22, 2026
- Quantity
- 44280 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Chiesi USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0689-2026, exactly as published.
Show all FDA fields
- City
- Cary
- State
- NC
- Status
- Ongoing
- Country
- United States
- Event ID
- 99376
- Address
- 175 Regency Woods Pl Ste 600
- Code information
- Lot #: 1239521, 1237454, Exp. Date 10/2027
- Postal code
- 27518-6007
- Report date
- Jul 22, 2026
- Product type
- Drugs
- Recall number
- D-0689-2026
- Classification
- Class II
- Recalling firm
- Chiesi USA, Inc.
- Product quantity
- 44280 vials
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 6, 2026
- Initial firm notification
- Letter
- Center classification date
- Jul 14, 2026