Prescription medicine
Epoetin Brand names: Retacrit, Procrit, Epogen
Epoetin (Retacrit) is a prescription medicine. No generic is listed; pharmacies paid $32.27 per mL (Epogen 2,000 units/mL vial) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the epoetin FDA label on DailyMed (effective June 22, 2025); every epoetin label on DailyMed.
Highlights of the record
FDA label of June 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning. Chronic Kidney Disease:
In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL ( 5.1 ).
No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks ( 2.2 ).
Use the lowest RETACRIT dose sufficient to reduce the need for red blood cell (RBC) transfusions ( 5.1 ). Cancer:
ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers ( 5.2 ).
Use the lowest dose to avoid RBC transfusions ( 2.4 ).
Use ESAs only for anemia from myelosuppressive chemotherapy ( 1.3 ).
ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure ( 1.5 ). […]
Used for
From the label: indications and usageRETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to o Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ).
Forms and strengths
Injection (solution); solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 4 of which 0 under generic applications, 4 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $32.27 per mL Epogen 2,000 units/mL vial
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2017 0 Class I among all firms' recalls; latest September 13, 2017
- FAERS reports
- 33,968 through July 30, 2026
What is epoetin used for?
From the label: indications and usageRETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to o Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). o Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ). o The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.3 ).
Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery ( 1.4 ). Limitations of Use RETACRIT has not been shown to improve quality of life, fatigue, or patient well-being ( 1.5 ). […]
Conditions named in the indications of epoetin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Erythropoiesis-stimulating Agent.
Source: FDA drug label (RETACRIT), Pfizer Laboratories Div Pfizer Inc, effective June 22, 2025 (SPL set 3af26b0d-8ad0-44e1-a538-8bdb5ab39374), via openFDA; the full label on DailyMed
What does the patient leaflet for epoetin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about RETACRIT?RETACRIT may cause serious side effects that can lead to death, including: For people with cancer: • Your tumor may grow faster and you may die sooner if you choose to take RETACRIT. Your healthcare provider will talk with you about these risks. For all people who take RETACRIT, including people with cancer or chronic kidney disease: • Serious heart problems, such as heart attack or heart failure, and stroke. You may die sooner if you are treated with RETACRIT to increase red blood cells (RBCs) to near the same level found in healthy people. • Blood clots. Blood clots may happen at any time while taking RETACRIT. If you are receiving RETACRIT for any reason and you are going to have surgery, talk to your healthcare provider about whether or not you need to take a blood thinner to lessen the chance of blood clots during or following surgery. Blood clots can form in blood vessels (veins), especially in your leg (deep venous thrombosis or DVT). Pieces of a blood clot may travel to the lungs and block the blood circulation in the lungs (pulmonary embolus). • Call your healthcare provider or get medical help right away if you have any of these symptoms: o Chest pain o Trouble breathing or shortness of breath o Pain in your legs, with or without swelling o A cool or pale arm or leg o Sudden confusion, trouble speaking, or trouble understanding others' speech o Sudden numbness or weakness in your face, arm, or leg, especially on one side of your body o Sudden trouble seeing o Sudden trouble walking, dizziness, loss of balance or coordination o Loss of consciousness (fainting) o Hemodialysis vascular access stops working See " What are the possible side effects of RETACRIT? " below for more information. […]
From the patient leaflet: How should I store RETACRIT?Do not shake RETACRIT. • Store RETACRIT vials in the carton it comes in to protect from light. • Store RETACRIT in the refrigerator between 36°F to 46°F (2°C to 8°C). • Do not freeze RETACRIT. Do not use the carton of RETACRIT multiple-dose vials if it that has been frozen or if the green area on the freeze strip indicator inside the RETACRIT carton looks white or cloudy. • Throw away multiple-dose vials of RETACRIT no later than 21 days from the first day that you put a needle into the vial. • Single-dose vials of RETACRIT should be used only one time. Throw the vial away after use even if there is medicine left in the vial. Keep RETACRIT and all medicines out of the reach of children.
Source: FDA drug label (RETACRIT), Pfizer Laboratories Div Pfizer Inc, effective June 22, 2025 (SPL set 3af26b0d-8ad0-44e1-a538-8bdb5ab39374), via openFDA; the full label on DailyMed
Is there a generic for epoetin (Retacrit)?
No generic epoetin is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for epoetin (Retacrit)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $32.27 per mL (Epogen 2,000 units/mL vial), about the same as a year earlier. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Epogen 2,000 units/mL vial (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Epogen 10,000 unit/mL vial | Brand | $161.80 per mL | n/a | n/a |
| Epogen 2,000 units/mL vial | Brand | $32.27 per mL | n/a | -0.3% |
| Epogen 4,000 unit/mL vial | Brand | $64.36 per mL | n/a | n/a |
| Procrit 10,000 unit/mL vial | Brand | $259.86 per mL | n/a | n/a |
| Procrit 20,000 units/mL vial | Brand | $521.47 per mL | n/a | +0.6% |
| Procrit 4,000 unit/mL vial | Brand | $104.28 per mL | n/a | n/a |
| Procrit 40,000 units/mL vial | Brand | $1,038.70 per mL | n/a | +0.3% |
| Retacrit 10,000 unit/mL vial | Brand | $112.68 per mL | n/a | +5% |
| Retacrit 2,000 unit/mL vial | Brand | $22.52 per mL | n/a | +5% |
| Retacrit 20,000 unit/mL vial | Brand | $224.79 per mL | n/a | +5% |
| Retacrit 40,000 unit/mL vial | Brand | $448.01 per mL | n/a | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has epoetin been recalled?
The FDA's Enforcement Report lists 2 recalls naming epoetin since 2017: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| September 13, 2017 | Class II | Amgen, Inc. | Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection. |
| August 4, 2017 | Class II | Amgen, Inc. | Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the epoetin label say about other medicines?
The epoetin label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name epoetin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Darbepoetin alfa | warnings and precautions | A randomized, double-blind, placebo-controlled, prospective trial of 4038 patients with: CKD not on dialysis (eGFR of 20 – 60 mL/min), anemia (hemoglobin levels ≤ 11 g/dL), and type 2 diabetes mellitus, patients were randomized to receive either darbepoetin alfa treatment or a matching placebo. |
| Heparin | warnings and precautions | Patients receiving RETACRIT may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis. |
Source: FDA drug label (RETACRIT), Pfizer Laboratories Div Pfizer Inc, effective June 22, 2025 (SPL set 3af26b0d-8ad0-44e1-a538-8bdb5ab39374), via openFDA; the full label on DailyMed
What do FAERS reports show for epoetin?
The FDA Adverse Event Reporting System holds 33,968 reports that list epoetin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7,298 are coded as a death and 12,375 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?
- Other erythropoiesis-stimulating agents
- the pharmacologic class, with prices and generics
- Epoetin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other