# FDA recall D-0399-2025

> **American Regent, Inc.** · Class II · drug recall initiated 2025-04-18.

## Product

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]

## Reason for recall

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0399-2025
- **Recalling firm:** American Regent, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-04-18
- **Report date:** 2025-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New Albany, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0399-2025

## Citation

> AI Analytics. FDA recall D-0399-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0399-2025. Source: US FDA. Licensed CC0.

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