FDA Drug recall D-0081-2025
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 On…
- FDA Drug
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of 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 On… by American Regent, citing presence of Particulate Matter: Potential for glass delamination from the vials.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0081-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-11 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Regent |
| Distribution | US |
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
Presence of Particulate Matter: Potential for glass delamination from the vials.
Identifiers
| ndc | 49230-530-01 |
|---|---|
| ndc | 49230-530-10 |
| ndc | 49230-530-25 |
| ndc | 49230-534-01 |
| ndc | 49230-534-10 |
| ndc | 49230-534-25 |
| code_info | Lot #s: 4206, 4210, Exp 05/31/2026; 4223, Exp 06/30/2026; 24231, 24237, Exp 07/31/2026. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0081-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.