Quick answers
- What is Allopurinol used for?
- The FDA-approved label (Aloprim, Mylan Institutional LLC, February 18, 2022) says: “ALOPRIM is indicated for the management of adult and pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Allopurinol have a boxed warning?
- The label we quote has no boxed warning, but 5 of 134 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Allopurinol?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated February 19, 2026). Ask your pharmacist about alternatives.
- Has Allopurinol been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started June 7, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Allopurinol?
- 47 companies list prescription products of Allopurinol in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Aphena Pharma Solutions - Tennessee, LLC.
What Allopurinol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ALOPRIM is indicated for the management of adult and pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy. …
— FDA label: Aloprim, Mylan Institutional LLC, effective February 18, 2022. Read the full label on DailyMed →
The FDA has 134 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.
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.
5 of 134 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Injection, powder, lyophilized, for solution |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 175 in the FDA NDC Directory |
| Brand names | Aloprim |
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| allopurinol 100 mg tablet | Generic | $0.0312 per tablet |
| allopurinol 200 mg tablet | Generic | $1.87 per tablet |
| allopurinol 300 mg tablet | Generic | $0.0522 per tablet |
NADAC list of November 4, 2026; these prices took effect on 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.
- Bryant Ranch Prepack20 products
- A-S Medication Solutions17 products
- Aphena Pharma Solutions - Tennessee, LLC13 products
- Preferred Pharmaceuticals Inc.9 products
- Remedyrepack Inc.8 products
- Northwind Health Company, LLC7 products
- PD-Rx Pharmaceuticals, Inc.6 products
- NuCare Pharmaceuticals, Inc.6 products
- Cardinal Health 107, LLC5 products
- Proficient Rx LP5 products
- Coupler LLC4 products
- St. Mary's Medical Park Pharmacy4 products
- Rising Pharma Holdings, Inc.3 products
- Leading Pharma, LLC3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Zydus Lifesciences Limited3 products
- Indoco Remedies Limited3 products
- Florida Pharmaceutical Products, LLC3 products
- Direct_Rx3 products
- XLCare Pharmaceuticals, Inc.2 products
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- Accord Healthcare Inc.2 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2 products
- Camber Pharmaceuticals, Inc.2 products
- Mylan Institutional Inc.2 products
- Dr. Reddy's Laboratories Limited2 products
- Mylan Pharmaceuticals Inc.2 products
- Actavis Pharma, Inc.2 products
- AvPAK2 products
- Aurobindo Pharma Limited2 products
- Chartwell RX, LLC2 products
- Unichem Pharmaceuticals (USA), Inc.2 products
- NCS HealthCare of KY, LLC dba Vangard Labs2 products
- Harman Finochem Limited2 products
- Sportpharm LLC2 products
- NorthStar RxLLC2 products
- Safecor Health LLC2 products
- American Health Packaging2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Par Health USA, LLC2 products
- Major Pharmaceuticals2 products
- Advanced Rx of Tennessee, LLC1 product
- Redpharm Drug1 product
- Gland Pharma Limited1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Mylan Institutional LLC1 product
- Fresenius Kabi USA, LLC1 product
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 |
|---|---|---|---|
| NDA016084 ZYLOPRIM | Casper Pharma LLC | August 19, 1966 | 22, latest September 21, 2023 2023: Labeling · 2023: Labeling · 2023: Labeling |
| NDA018832 ALLOPURINOL | Watson Labs | September 28, 1984 | 26, latest April 3, 2024 2024: Labeling · 2024: Labeling · 2024: Labeling |
| NDA018877 ALLOPURINOL | Watson Labs | September 28, 1984 | 26, latest April 3, 2024 2024: Labeling · 2024: Labeling · 2024: Labeling |
| NDA020298 ALOPRIM | Mylan | May 17, 1996 | 7, latest February 17, 2022 2022: Labeling · 2020: Labeling · 2020: Labeling |
Generic approvals (15)
- ANDA018659Mylan · October 24, 1986
- ANDA071450Sun Pharm Industries · January 9, 1987
- ANDA071587DR Reddys · April 2, 1987
- ANDA075798Ph Health · June 27, 2003
- ANDA076870Hikma · August 26, 2004
- ANDA077353Chartwell · September 8, 2005
- ANDA203154Accord Hlthcare · May 6, 2013
- ANDA204467Regcon Holdings · July 28, 2016
- ANDA210117Zydus Pharms · October 12, 2017
- ANDA211820Unichem · March 12, 2019
- ANDA212363Gland · January 26, 2022
- ANDA214443Harman Finochem · March 7, 2022
- ANDA217748Hetero Labs Ltd V · August 3, 2023
- ANDA215091Aurobindo Pharma Ltd · April 14, 2025
- ANDA071586—
Shortage status
To be discontinued · updated February 19, 2026 · first posted February 19, 2026
| Product | Allopurinol, Tablet, 100 mg (NDC 0591-5543-01) |
|---|---|
| Company | Teva Pharmaceuticals USA, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
June 7, 2024 · Class II · Terminated · D-0583-2024
Presence of foreign substance.
Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106 USA, NDC 55111-730-01. — Dr. Reddy's Laboratories, Inc.
-
January 12, 2023 · Class II · Terminated · D-0168-2023
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India. NDC 16729-134-01 — Accord Healthcare, Inc.
-
January 26, 2022 · Class II · Terminated · D-0164-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106. NDC: 55111-730-05 — CARDINAL HEALTHCARE
-
May 5, 2020 · Class II · Terminated · D-1271-2020
Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.
Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA. NDC: 67457-187-50 — Mylan Institutional LLC
-
July 20, 2015 · Class III · Terminated · D-1405-2015
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28 — Qualitest Pharmaceuticals
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Aloprim, Mylan Institutional LLC, effective February 18, 2022; 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 →