Quick answers
- What is Sodium ferric gluconate complex used for?
- The FDA-approved label (Ferrlecit, sanofi-aventis U.S. LLC, October 7, 2025) says: “Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sodium ferric gluconate complex have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sodium ferric gluconate complex?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sodium ferric gluconate complex been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started November 17, 2016 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Sodium ferric gluconate complex?
- 2 companies list prescription products of Sodium ferric gluconate complex in the FDA NDC Directory, including Sanofi-Aventis U.S. LLC and Hikma Pharmaceuticals USA Inc..
What Sodium ferric gluconate complex is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. …
— FDA label: Ferrlecit, sanofi-aventis U.S. LLC, effective October 7, 2025. Read the full label on DailyMed →
The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Ferrlecit |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Sanofi-Aventis U.S. LLC2 products
- Hikma Pharmaceuticals USA Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020955 FERRLECIT | Sanofi Aventis Us | February 18, 1999 | 12, latest March 16, 2022 2022: Labeling · 2020: Labeling · 2020: Labeling |
Generic approvals (1)
- ANDA078215Hikma · March 31, 2011
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
November 17, 2016 · Class III · Terminated · D-0172-2017
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only, Mfd: Hikma Farmaceutica (Portugal,) SA Distributed by: Westward Eatowntown NJ 07724 USA, Shelf pack — West-Ward Pharmaceuticals Corp.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 242761, 261123 |
|---|---|
| SPL set ID of the quoted label | b25b34ab-9cf1-4a2b-bdf2-5eaf66625999 |
| FDA labels (SPL) | 4 |
| FDA applications | NDA020955, 1 ANDA |
| Active ingredients (FDA) | SODIUM FERRIC GLUCONATE COMPLEX |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ferrlecit, sanofi-aventis U.S. LLC, effective October 7, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →