Prescription Drug Recall: Venofer Iron Sucrose Vials with Glass Delamination Risk
American Regent, Inc. is recalling specific lots of Venofer (iron sucrose) injection due to potential glass delamination in vials. The intravenous drug distributed nationwide may contain particulate matter.
What this means for you
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: This is an FDA Class II recall for potential glass delamination and particulate matter in an intravenous injection product. While the defect poses a risk of harm from glass contamination in an injectable medication, no illnesses or injuries have been reported, which limits the score to 3 per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Venofer (iron sucrose) Injection, USP is a prescription intravenous medication distributed nationwide. American Regent, Inc. is recalling specific lots due to the presence of particulate matter and potential for glass delamination from the vials.
The affected lots are: Lot #4205 (expiration 05/31/2026) and Lots #24229, 24233, and 24239 (expiration 07/31/2026). The product was distributed to healthcare facilities nationwide in the United States.
Healthcare providers and patients using affected lots should not use the recalled medication. Contact American Regent, Inc. or your healthcare provider for instructions on obtaining replacement product or alternative treatment. No illnesses or injuries related to this recall have been reported to date.
The recalled product
- Product
- VENOFER (IRON SUCROSE)
- Brand
- VENOFER
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Intravenous Injectable
- Hazard
- glass-delamination
- particulate-matter
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 (6)
- Lot #s: 4205
- Exp 05/31/2026
- 24229
- 24233
- 24239
- Exp 07/31/2026.
UPCs (2)
- 0305172340016
- 0305172340252
Distribution
Distributed nationwide across the United States.
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