Quick answers
- What is Tacrolimus used for?
- The FDA-approved label (Prograf, Astellas Pharma US, Inc., August 25, 2023) says: “PROGRAF is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tacrolimus have a boxed warning?
- Yes. The FDA label for Prograf has a boxed warning (“WARNING: MALIGNANCIES AND SERIOUS INFECTIONS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Tacrolimus?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tacrolimus been recalled?
- FDA enforcement reports list 9 recalls of products of this medicine; the newest started December 23, 2024 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Tacrolimus?
- 36 companies list prescription products of Tacrolimus in the FDA NDC Directory, including Astellas Pharma US, Inc., Bryant Ranch Prepack and Glenmark Pharmaceuticals Inc., USA.
What Tacrolimus is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PROGRAF is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. …
— FDA label: Prograf, Astellas Pharma US, Inc., effective August 25, 2023. Read the full label on DailyMed →
The FDA has 43 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.
This label has a boxed warning. Its heading: WARNING: MALIGNANCIES AND SERIOUS INFECTIONS
. Read it on the full label →
41 of 43 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Capsule, gelatin coated · Ointment · Capsule, coated, extended release · Tablet, extended release · Capsule, extended release · Granule, for suspension · Injection · Injection, solution |
|---|---|
| Route | Oral · Topical · Intravenous |
| Prescription products | 106 in the FDA NDC Directory |
| Brand names | Prograf, Envarsus XR, Astagraf XL |
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 |
|---|---|---|
| tacrolimus 0.03% ointment | Generic | $0.9501–$1.07 per gram 9 packages, lowest to highest |
| tacrolimus 0.1% ointment | Generic | $1.01–$1.07 per gram 12 packages, lowest to highest |
| tacrolimus 0.2 mg granule, for suspension | Brand: Prograf | $5.02 per unit |
| tacrolimus 0.5 mg capsule | Generic | $0.1192 per capsule |
| tacrolimus 0.5 mg capsule, coated, extended release | Brand: Astagraf XL | $2.88 per capsule |
| tacrolimus 0.5 mg capsule, gelatin coated | Generic | $0.1192 per capsule |
| tacrolimus 0.5 mg capsule, gelatin coated | Brand: Prograf | $3.66 per capsule |
| tacrolimus 1 mg capsule | Generic | $0.1598 per capsule |
| tacrolimus 1 mg capsule, coated, extended release | Brand: Astagraf XL | $5.71 per capsule |
| tacrolimus 1 mg capsule, gelatin coated | Generic | $0.1598 per capsule |
| tacrolimus 1 mg capsule, gelatin coated | Brand: Prograf | $7.34 per capsule |
| tacrolimus 1 mg granule, for suspension | Brand: Prograf | $7.44 per unit |
| tacrolimus 5 mg capsule | Generic | $0.6880 per capsule |
| tacrolimus 5 mg capsule, gelatin coated | Generic | $0.6880 per capsule |
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.
- Astellas Pharma US, Inc.9 products
- Bryant Ranch Prepack6 products
- Glenmark Pharmaceuticals Inc., USA5 products
- Accord Healthcare Inc.5 products
- Sandoz Inc3 products
- Stellon Biotech Inc.3 products
- Safecor Health LLC3 products
- Chengdu Suncadia Medicine Co., Ltd.3 products
- Ajenat Pharmaceuticals LLC3 products
- MylanInstitutional Inc.3 products
- BPI Labs LLC3 products
- Jubilant Cadista Pharmaceuticals Inc.3 products
- Ascend Laboratories, LLC3 products
- American Health Packaging3 products
- Concord Biotech Limited3 products
- Veloxis Pharmaceuticals, Inc3 products
- NorthStar Rx LLC3 products
- Dr. Reddy's Laboratories Limited3 products
- Golden State Medical Supply, Inc.3 products
- Amneal Pharmaceuticals NY LLC3 products
- Biocon Pharma Inc.3 products
- Mylan Pharmaceuticals Inc.3 products
- Major Pharmaceuticals3 products
- Panacea Biotec Limited3 products
- Quallent Pharmaceuticals Health LLC3 products
- Strides Pharma Science Limited3 products
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC2 products
- Cardinal Health 107, LLC2 products
- A-S Medication Solutions2 products
- AvPAK2 products
- Padagis Israel Pharmaceuticals Ltd2 products
- Proficient Rx LP1 product
- Nexus Pharmaceuticals LLC1 product
- Encube Ethicals, Inc.1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
- Direct_Rx1 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 |
|---|---|---|---|
| NDA050708 PROGRAF | Astellas | April 8, 1994 | 36, latest September 14, 2023 2023: Labeling · 2022: Labeling · 2021: Efficacy |
| NDA050709 PROGRAF | Astellas | April 8, 1994 | 28, latest November 22, 2022 2022: Labeling · 2021: Efficacy · 2020: Labeling |
| NDA050777 PROTOPIC | Leo Pharma As | December 8, 2000 | 10, latest February 25, 2019 2019: Manufacturing (CMC) · 2011: Labeling · 2008: Manufacturing (CMC) |
| NDA204096 ASTAGRAF XL | Astellas | July 19, 2013 | 9, latest September 14, 2023 2023: Labeling · 2022: Labeling · 2020: Labeling |
| NDA206406 ENVARSUS XR | Veloxis Pharms Inc | July 10, 2015 | 9, latest April 8, 2024 2024: Labeling · 2023: Labeling · 2020: Labeling |
| NDA210115 PROGRAF | Astellas | May 24, 2018 | 6, latest September 14, 2023 2023: Labeling · 2022: Labeling · 2021: Efficacy |
Generic approvals (17)
- ANDA065461Sandoz · August 10, 2009
- ANDA090509DR Reddys Labs Ltd · May 12, 2010
- ANDA090596Mylan · September 17, 2010
- ANDA091195Accord Hlthcare · August 31, 2011
- ANDA090802Panacea · September 28, 2012
- ANDA090687Strides Pharma · July 22, 2014
- ANDA200744Fougera Pharms Inc · September 9, 2014
- ANDA206651Ajenat Pharms · November 30, 2017
- ANDA210393Glenmark Pharms Ltd · April 16, 2018
- ANDA211688Accord Hlthcare · January 31, 2019
- ANDA206662Glenmark Pharms Ltd · November 10, 2020
- ANDA212297Biocon Pharma · November 10, 2020
- ANDA213112Concord Biotech Ltd · November 10, 2020
- ANDA203740Alkem Labs Ltd · November 12, 2020
- ANDA212387Encube · October 10, 2023
- ANDA215012Chengdu · January 25, 2024
- ANDA217108Nexus · February 12, 2025
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.
-
December 23, 2024 · Class I · Ongoing · D-0211-2025
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73. — Astellas Pharma US Inc.
-
December 23, 2024 · Class I · Ongoing · D-0210-2025
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73. — Astellas Pharma US Inc.
-
December 15, 2023 · Class II · Terminated · D-0219-2024
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01 — Dr. Reddy's Laboratories, Inc.
-
February 8, 2023 · Class II · Ongoing · D-0330-2023
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01. — Dr. Reddy's Laboratories, Inc.
-
July 11, 2022 · Class III · Ongoing · D-1304-2022
Defective Container: Tube split from side seam
Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmac — Glenmark Pharmaceuticals Inc., USA
-
December 22, 2020 · Class III · Terminated · D-0180-2021
Failed Moisture Limits
NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 — Strides Pharma Inc.
-
March 23, 2020 · Class III · Terminated · D-1057-2020
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01 — Mylan Pharmaceuticals Inc.
-
October 22, 2013 · Class II · Terminated · D-383-2014
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01 — Sandoz Incorporated
-
June 29, 2012 · Class II · Terminated · D-066-2013
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01 — Mylan LLC.
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) | 108513, 108514, 108515, 198377, 198378, 198379, 261134, 313189, 313190, 314266 … (+10) |
|---|---|
| SPL set ID of the quoted label | 7f667de1-9dfa-4bd6-8ba0-15ee2d78873b |
| FDA labels (SPL) | 43 |
| FDA applications | NDA050708, NDA050709, NDA050777, NDA204096, NDA206406, NDA210115, 17 ANDA |
| Active ingredients (FDA) | TACROLIMUS |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Prograf, Astellas Pharma US, Inc., effective August 25, 2023; 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 →