Prescription medicine
Ferrous sulfate
Ferrous sulfate is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ferrous sulfate FDA label on DailyMed (effective July 12, 2022); every ferrous sulfate label on DailyMed.
Highlights of the record
FDA label of July 12, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
The label in openFDA carries no indications section.
Forms and strengths
- 325 mg
Tablet.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest March 15, 2021; 3 more by firms not listed as its makers
- FAERS reports
- 49,926 through July 30, 2026
Is there a generic for ferrous sulfate?
No generic ferrous sulfate is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has ferrous sulfate been recalled?
The FDA's Enforcement Report lists 5 recalls naming ferrous sulfate since 2013: 0 Class I (the most serious), 4 Class II, 1 Class III; 1 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of ferrous sulfate and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 17, 2025 | Class II | Safecor Health, LLC not a listed maker | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| April 10, 2018 | Class III | Aidarex Pharmaceuticals LLC | Presence of Foreign Tablets/Capsules |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe) may be potentially mislabeled as COENZYME Q-10, Capsule, 100 mg, NDC 37205055065 … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elemental Iron) may be potentially mislabeled as RAMIPRIL, Capsule, 2.5 mg, NDC 68180058901 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ferrous sulfate label say about other medicines?
The ferrous sulfate label names no other medicine on this site. The labels of 2 other medicines name ferrous sulfate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Source: FDA drug label (Ferrum Sulphuricum), Hahnemann Laboratories, INC., effective July 12, 2022 (SPL set e3a5f645-9d34-1a6d-e053-2995a90a030e), via openFDA; the full label on DailyMed
What do FAERS reports show for ferrous sulfate?
The FDA Adverse Event Reporting System holds 49,926 reports that list ferrous sulfate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,593 are coded as a death and 21,519 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Ferrous sulfate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other