Quick answers
- What is Fyarro?
- Fyarro is a brand name of Sirolimus, a prescription medicine. The FDA NDC Directory lists 1 Fyarro product in 1 strength and form.
- Who makes Fyarro?
- Aadi holds the FDA application for Fyarro (NDA213312, approved November 22, 2021).
- Is there a generic or store brand of Fyarro?
- Other products of Sirolimus are listed with the FDA, but none in exactly the same strength and form as a Fyarro product.
- Has Fyarro been recalled?
- FDA enforcement reports list 1 recall of Fyarro products; the newest started October 13, 2022. A recall usually concerns specific lots, not every product.
What Fyarro is
Each Fyarro product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Sirolimus · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| sirolimus 5 mg/mL injection, powder, lyophilized, for suspension (intravenous) | Fyarro | None listed | — |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Sirolimus →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA213312 | Aadi | November 22, 2021 | 1 |
Companies that list Fyarro
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Fyarro products.
- Aadi Bioscience, Inc.1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
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
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.