Multi event Drug Recall Enforcement Report Class II voluntary initiated by American Regent, Inc., originally initiated on 11-11-2024 for the 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). The product was recalled due to presence of particulate matter: potential for glass delamination from the vials.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0081-2025 | 11-11-2024 | 12-11-2024 | Class II | | 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). | Presence of Particulate Matter: Potential for glass delamination from the vials. | Ongoing |
| D-0080-2025 | 11-11-2024 | 12-11-2024 | Class II | | 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). | Presence of Particulate Matter: Potential for glass delamination from the vials. | Ongoing |
| D-0082-2025 | 11-11-2024 | 12-11-2024 | Class II | | 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, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons). | Presence of Particulate Matter: Potential for glass delamination from the vials. | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0517-2310 | Venofer | Iron Sucrose | Injection, Solution | Intravenous | American Regent, Inc. | Human Prescription Drug |
| 0517-2325 | Venofer | Iron Sucrose | Injection, Solution | Intravenous | American Regent, Inc. | Human Prescription Drug |
| 0517-2340 | Venofer | Iron Sucrose | Injection, Solution | Intravenous | American Regent, Inc. | Human Prescription Drug |
| 0517-2340 | Venofer | Iron Sucrose | Injection, Solution | Intravenous | American Regent, Inc. | Human Prescription Drug |
| 49230-530 | Venofer | Iron Sucrose | Injection, Solution | Intravenous | Fresenius Medical Care Holdings, Inc. | Human Prescription Drug |
| 49230-534 | Venofer | Iron Sucrose | Injection, Solution | Intravenous | Fresenius Medical Care Holdings, Inc. | Human Prescription Drug |
