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Prescription medicine

Epoetin alfa-epbx

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Epoetin alfa-epbx used for?
The FDA-approved label (Retacrit, Vifor (International) Inc., June 22, 2025) says: “RETACRIT 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. o Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection. o The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Epoetin alfa-epbx have a boxed warning?
Yes. The FDA label for Retacrit has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Epoetin alfa-epbx?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Epoetin alfa-epbx been recalled?
FDA enforcement reports list 2 recalls of products of this medicine; the newest started September 13, 2017 (Class II). A recall usually concerns specific lots, not every product.
Who makes Epoetin alfa-epbx?
4 companies list prescription products of Epoetin alfa-epbx in the FDA NDC Directory, including Janssen Products, LP, Pfizer Laboratories Div Pfizer Inc and Amgen, Inc.

What Epoetin alfa-epbx is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

RETACRIT 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. o Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection. o The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. …

— FDA label: Retacrit, Vifor (International) Inc., effective June 22, 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.

This label has a boxed warning. Read it on the full label →

4 of 4 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection, solution · Solution
RouteIntravenous · Subcutaneous
Prescription products26 in the FDA NDC Directory
Brand namesRetacrit, Procrit, Epogen

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Epoetin alfa-epbx, by strength and form
Strength and formGeneric or brandPharmacies pay
epoetin 10000 units/mL
injection, solution
Brand: Procrit $259.94 per mL
epoetin 10000 units/mL
injection, solution
Brand: Retacrit $112.68 per mL
epoetin 10000 units/mL
solution
Brand: Epogen $161.82 per mL
epoetin 2000 units/mL
injection, solution
Brand: Retacrit $22.52 per mL
epoetin 2000 units/mL
solution
Brand: Epogen $32.27 per mL
epoetin 20000 units/mL
injection, solution
Brand: Procrit $521.36 per mL
epoetin 20000 units/mL
injection, solution
Brand: Retacrit $224.79 per mL
epoetin 4000 units/mL
injection, solution
Brand: Procrit $104.28 per mL
epoetin 4000 units/mL
solution
Brand: Epogen $64.36 per mL
epoetin 40000 units/mL
injection, solution
Brand: Procrit $1,038.70 per mL
epoetin 40000 units/mL
injection, solution
Brand: Retacrit $448.01 per mL

NADAC list of November 4, 2026; these prices took effect between December 17, 2025 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

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.

FDA approval history

  • BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
BLA103234
EPOGEN/PROCRIT
AmgenJune 1, 1989 35, latest April 30, 2024
2024: Labeling · 2018: Labeling · 2017: Labeling
BLA125545
RETACRIT
Hospira IncMay 15, 2018 4, latest June 4, 2024
2024: Labeling · 2023: Labeling · 2020: Efficacy

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

  1. September 13, 2017 · Class II · Terminated · D-1173-2017

    Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.

    Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials (NDC 59676-310-01), b) box of 25 single use 1 mL vials (NDC 59676-310-02), Rx Only, Manufactured by: Amgen, Inc. Thousand Oaks, CA 91 — Amgen, Inc.

  2. August 4, 2017 · Class II · Terminated · D-1086-2017

    Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.

    Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044 — Amgen, Inc.

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)205912, 205913, 205917, 205918, 205921, 205922, 205923, 205924, 212218, 212219 … (+10)
SPL set ID of the quoted labele6e4dd0c-25ca-40b2-ba6b-6138a68621fe
FDA labels (SPL)4
FDA applicationsBLA103234, BLA125545
Active ingredients (FDA)EPOETIN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Retacrit, Vifor (International) Inc., effective June 22, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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