Venofer — Class II drug recall D-0080-2025
Ongoing recall by American Regent, Inc., reported 2024-12-11, distributed nationwide. Presence of Particulate Matter: Potential for glass delamination from the vials.
| Recall number | D-0080-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Regent, Inc., Shirley, NY, United States |
| Recall initiated | 2024-11-11 |
| Classified | 2024-11-29 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Reason classes | foreign material, specification failure |
| NDC | 49230-0530, 49230-0530-01, 49230-0530-10, 49230-0530-25, 49230-0534, 49230-0534-01, 49230-0534-10, 49230-0534-25 |
| Lot numbers | 4196 |
| Expiration dates | 2026-05-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0080-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.