American Regent, Inc. 2024-12-11 Health serious FDA
Health · FDA · Recall #FDA-D-0081-2025
Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL… Recall
Issued December 11, 2024 · American Regent, Inc.
In December 2024, American Regent, Inc. recalled the Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Presence of Particulate Matter: Potential for glass delamination from the vials.
What you should do
- 1 Stop using Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact American Regent, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- American Regent, Inc.
- Category
- Health
- Recall date
- December 11, 2024
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-0081-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- American Regent, Inc. has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.