Quick answers
- What is Sirolimus used for?
- The FDA-approved label (Hyftor, Nobelpharma America, LLC, August 22, 2025) says: “HYFTOR is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older. HYFTOR is an mTOR inhibitor immunosuppressant indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sirolimus have a boxed warning?
- The label we quote has no boxed warning, but 19 of 21 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Sirolimus?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sirolimus been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started May 1, 2024 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Sirolimus?
- 20 companies list prescription products of Sirolimus in the FDA NDC Directory, including Mylan Pharmaceuticals Inc., Remedyrepack Inc. and NorthStar Rx LLC.
What Sirolimus is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
HYFTOR is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older. HYFTOR is an mTOR inhibitor immunosuppressant indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older.
— FDA label: Hyftor, Nobelpharma America, LLC, effective August 22, 2025. Read the full label on DailyMed →
The FDA has 21 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.
19 of 21 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 |
|---|---|---|
| sirolimus 0.5 mg tablet, film coated | Generic | $0.8326 per tablet |
| sirolimus 0.5 mg tablet, sugar coated | Generic | $0.8326 per tablet |
| sirolimus 1 mg tablet | Generic | $0.7127 per tablet |
| sirolimus 1 mg tablet, film coated | Generic | $0.7127 per tablet |
| sirolimus 1 mg tablet, sugar coated | Generic | $0.7127 per tablet |
| sirolimus 1 mg/mL solution | Generic | $4.21 per mL |
| sirolimus 2 mg tablet | Generic | $2.35 per tablet |
| sirolimus 2 mg tablet, film coated | Generic | $2.35 per tablet |
| sirolimus 2 mg tablet, sugar coated | Generic | $2.35 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.
- Mylan Pharmaceuticals Inc.4 products
- Remedyrepack Inc.4 products
- NorthStar Rx LLC4 products
- Ascend Laboratories, LLC3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Zydus Lifesciences Limited3 products
- Glenmark Pharmaceuticals Inc., USA3 products
- American Health Packaging2 products
- Dr. Reddy's Laboratories Limited2 products
- AvPAK2 products
- Major Pharmaceuticals1 product
- Apotex Corp.1 product
- Novadoz Pharmaceuticals LLC1 product
- Amneal Pharmaceuticals NY LLC1 product
- Camber Pharmaceuticals, Inc.1 product
- VistaPharm, LLC1 product
- Nobelpharma America, LLC1 product
- Rising Pharma Holdings, Inc.1 product
- Bryant Ranch Prepack1 product
- Aadi Bioscience, Inc.1 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 |
|---|---|---|---|
| NDA021083 RAPAMUNE | Pf Prism Cv | September 15, 1999 | 57, latest August 22, 2022 2022: Labeling · 2022: Labeling · 2020: Labeling |
| NDA021110 RAPAMUNE | Pf Prism Cv | August 25, 2000 | 64, latest August 22, 2022 2022: Labeling · 2022: Labeling · 2021: Labeling |
| NDA213312 FYARRO | Aadi | November 22, 2021 | 1, latest September 2, 2026 2026: Labeling |
| NDA213478 HYFTOR | Nobelpharma | March 22, 2022 | — |
Generic approvals (10)
- ANDA201676Zydus Pharms · January 8, 2014
- ANDA201578DR Reddys · October 27, 2014
- ANDA211040Novitium Pharma · January 28, 2019
- ANDA211212Amneal · October 18, 2019
- ANDA211406Apotex · October 22, 2019
- ANDA208691Glenmark Pharms Ltd · October 16, 2020
- ANDA214753Alkem Labs Ltd · March 12, 2021
- ANDA216728Msn · January 19, 2023
- ANDA215080Hetero Labs Ltd V · September 16, 2024
- ANDA215116Rising · July 15, 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.
-
May 1, 2024 · Class III · Ongoing · D-0504-2024
Failed Impurities/Degradation Specifications
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01 — Dr. Reddy's Laboratories, Inc.
-
October 13, 2022 · Class III · Terminated · D-0059-2023
Failed Stability Specifications
Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA. — Aadi Bioscience
-
May 3, 2022 · Class III · Terminated · D-0881-2022
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2 — Apotex Corp.
-
May 12, 2021 · Class III · Terminated · D-0813-2021
Failed Impurities/Degradation Specifications
Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25 — American Health Packaging
-
June 3, 2016 · Class III · Terminated · D-1063-2016
Failed impurities/degradation: out of specification result for impurity secorapamycin.
Sirolimus Tablets, 1 mg, 100-count bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Visakhapatnam - 5300046 India, NDC 55111-653-01 — Dr. Reddy's Laboratories, 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Hyftor, Nobelpharma America, LLC, effective August 22, 2025; 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 →