Iron sucrose injection recall due to potential glass contamination in vials
VENOFER (iron sucrose) injection is being recalled nationwide because certain vials may contain glass particles from potential glass delamination. Patients and healthcare providers should contact their pharmacist or healthcare provider immediately.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving potential glass particle contamination in an intravenous medication. The hazard presents a genuine risk of harm to patients receiving injections, though no illnesses or injuries have been reported in the source material.
Plain-English summary
VENOFER (iron sucrose) Injection, USP is being recalled nationwide by American Regent, Inc. The product is a prescription injectable medication containing 50 mg of elemental iron per 2.5 mL vial, used for intravenous administration and distributed by Fresenius Medical Care NA, Waltham, MA.
The recall affects the following lot numbers: 4206 and 4210 (expiring 05/31/2026), 4223 (expiring 06/30/2026), and 24231 and 24237 (expiring 07/31/2026). The affected product is available in single-dose vials and carton packaging with NDC codes 49230-530-01, 49230-530-10, and 49230-530-25.
The recall was initiated due to the presence of particulate matter in the vials, specifically potential for glass delamination. Glass particles could contaminate the medication and pose a health risk to patients receiving intravenous injections.
Patients currently using this medication should contact their healthcare provider or pharmacist immediately, particularly if they have received injections from affected lot numbers. Healthcare providers should review patient records to identify anyone who may have received doses from the recalled lots and consider appropriate clinical follow-up.
The recalled product
- Product
- VENOFER (IRON SUCROSE)
- Brand
- VENOFER
- Manufacturer
- American Regent, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot #s: 4206
- 4210
- Exp 05/31/2026
- 4223
- Exp 06/30/2026
- 24231
- 24237
- Exp 07/31/2026.
UPCs (2)
- 0349230530254
- 0349230534252
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by American Regent, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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