Venofer Iron Sucrose Injection Recalled for Potential Glass Contamination
American Regent is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination from vials. The affected drug is distributed nationwide.
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 with potential for glass contamination in intravenous medication. No reported illnesses or injuries. The theoretical risk of glass particle contamination in an injectable drug warrants High severity despite lack of confirmed incidents.
Plain-English summary
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL, is being recalled due to the potential for glass delamination from vials. The recalled lot is Lot 4196, with an expiration date of May 31, 2026. This product is distributed nationwide.
The presence of particulate matter resulting from glass delamination in the vials could pose a risk to patients receiving this intravenous medication. This is a Class II recall.
Healthcare providers and patients should discontinue use of the affected lot. Patients who have received medication from this lot should contact their healthcare provider with any questions or concerns.
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 (2)
- Lot#s: 4196
- Exp 05/31/2026
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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