Food, drugs, devices › American Regent, Inc.
Drug recall: niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenou
FDA enforcement event 94621 is a drug recall by American Regent, Inc. of New Albany, OH, initiated 14 May 2024 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 71% of the 319 drug enforcement events initiated in 2024 carry the same class.
Status: Terminated, terminated 23 Dec 2025. Initiation: voluntary: firm initiated. American Regent, Inc. has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
American Regent, Inc., New Albany, OH.
Reason for recall
"Lack of Assurance of Sterility."
Distribution
"UT only"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0503-2024 | niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10 | 4,136 cartons (10 vials in each carton) | Class II | Terminated | 29 May 2024 |
Context
Other enforcement events for American Regent, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 11 Aug 2026 | Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramusc | Drug | Class I | 1 |
| 24 Jul 2026 | Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (ND | Drug | Class I | 12 |
| 16 Apr 2026 | Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent | Drug | Class III | 1 |
| 18 Apr 2025 | niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc | Drug | Class II | 2 |
| 11 Nov 2024 | Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For In | Drug | Class II | 3 |
| 13 May 2024 | Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous In | Drug | Class II | 1 |
All 7 events for American Regent, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Lack of Assurance of Sterility."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "UT only"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 23 Dec 2025. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.