Iron Sucrose recalls

The FDA has published 4 recalls involving Iron Sucrose since 2019. The latest was reported on 11 Dec 2024. Most were for particulate matter. American Regent has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls4since 2019

Last 12 months0reported

Class I00% of total

Ongoing3latest 11 Dec 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 3 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 100%Class III 0 0%

Why iron sucrose is recalled

Particulate Matter375%
Sterility125%

Companies

American Regent375%
Infusion Options125%

By year

2024375%
2019125%

Ongoing iron sucrose recalls

3 active

Reported	Class	Recall	Company	Reason	Where
11 Dec 2024Drug	CLASS II	Venofer (iron sucrose) Injection recalled by American RegentVenofer	American Regent	Particulate Matter	Nationwide
11 Dec 2024Drug	CLASS II	Venofer (iron sucrose) Injection recalled by American RegentVenofer	American Regent	Particulate Matter	Nationwide
11 Dec 2024Drug	CLASS II	Venofer (iron sucrose) Injection recalled by American RegentVenofer	American Regent	Particulate Matter	Nationwide

All iron sucrose recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
11 Dec 2024Drug	CLASS II	Venofer (iron sucrose) Injection recalled by American RegentVenofer	American Regent	Particulate Matter	Nationwide
11 Dec 2024Drug	CLASS II	Venofer (iron sucrose) Injection recalled by American RegentVenofer	American Regent	Particulate Matter	Nationwide
11 Dec 2024Drug	CLASS II	Venofer (iron sucrose) Injection recalled by American RegentVenofer	American Regent	Particulate Matter	Nationwide
21 Aug 2019Drug	CLASS II	Iron Sucrose 200 mg / NS Ivpb recalled by Infusion Options	Infusion Options	Sterility	NY

Should you stop taking Iron Sucrose?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.