# FDA recall D-0080-2025

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

## Product

Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/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-0080-2025
- **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-0080-2025

## Citation

> AI Analytics. FDA recall D-0080-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0080-2025. Source: US FDA. Licensed CC0.

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