Multi event Drug Recall Enforcement Report Class II voluntary initiated by American Regent, Inc., originally initiated on 04-18-2025 for the product niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01. The product was recalled due to lack of sterility assurance: product leakage around the vial neck, which could potentially result in a lack of sterility assurance.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0398-2025 | 04-18-2025 | 05-07-2025 | Class II | 29,777 (cartons of 10 x 10mL vials) | niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01. | Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. | Ongoing |
| D-0399-2025 | 04-18-2025 | 05-07-2025 | Class II | 7,249 (cartons of 10 x 10 mL vials) | niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01] | Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0517-0735 | Nicardipine Hydrochloride | Nicardipine Hydrochloride | Injection, Solution | Intravenous | American Regent, Inc. | Human Prescription Drug |
| 72572-470 | Nicardipine Hydrochloride | Nicardipine Hydrochloride | Injection, Solution | Intravenous | Civica, Inc. | Human Prescription Drug |
