---
title: "niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL... — FDA record D-0503-2024 | Is It on Recall"
description: "Lack of Assurance of Sterility."
url: https://isitonrecall.com/recall/fda-drug-d-0503-2024-nicardipine-hydrochloride-injection-usp-25-mg-10-ml-2-5-mg-ml-10-x-10-ml-single-dose-vials-rx-only-f/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intrave... — FDA record D-0503-2024

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 14, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: 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
- **Reason**: Lack of Assurance of Sterility.
- **Classification**: Class II
- **Recalling firm**: American Regent, Inc.
- **Quantity**: 4,136 cartons (10 vials in each carton)
- **Agency-reported status**: Terminated
- **Source record identifier**: D-0503-2024

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0503-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot #: 23087N0C0, Exp. Date 11/2024 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

UT only

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Utah](https://isitonrecall.com/state/utah/)

## Dates in the source

- **Report date**: May 29, 2024
- **Recall initiation date**: May 14, 2024
- **Center classification date**: May 21, 2024
- **Termination date**: Dec 23, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0503-2024%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [American Regent, Inc. records](https://isitonrecall.com/brand/american-regent-inc/)