# FDA recall D-0081-2025

> **American Regent, Inc.** · Class II · drug recall initiated 2024-11-11.

## Product

Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons).

## Reason for recall

Presence of Particulate Matter: Potential for glass delamination from the vials.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0081-2025
- **Recalling firm:** American Regent, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-11-11
- **Report date:** 2024-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Shirley, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0081-2025

## Citation

> AI Analytics. FDA recall D-0081-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0081-2025. Source: US FDA. Licensed CC0.

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