FDAFDA · Food and drugs·Recall number D-0802-2026
niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054.
Published August 26, 2026 · Recall initiated: July 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- NICARDIPINE HYDROCHLORIDE
- Manufacturer
- American Regent, Inc.
- Distributor
- Nationwide within the U.S
- Lot
- Lot #: 25295N0C0, Exp. Date: 04/30/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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