Quick answers
- Is there a shortage of Risdiplam?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Risdiplam been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 20, 2021 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Risdiplam?
- 1 company lists prescription products of Risdiplam in the FDA NDC Directory, including Genentech, Inc..
What Risdiplam is used for
We did not find an “Indications and Usage” section in the FDA labels for this medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Forms and how it is given
| Dosage forms | Tablet · Powder, for solution |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Evrysdi |
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.
- Genentech, Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA213535 EVRYSDI | Genentech Inc | August 7, 2020 | 13, latest September 14, 2026 2026: Labeling · 2026: Labeling · 2026: Labeling |
| NDA219285 EVRYSDI | Genentech Inc | February 11, 2025 | 3, latest September 14, 2026 2026: Labeling · 2026: Labeling · 2026: Labeling |
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.
-
April 20, 2021 · Class III · Terminated · D-0357-2021
Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, Inc. NDC:50242-175-05 — Genentech 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
| FDA labels (SPL) | 0 |
|---|---|
| FDA applications | NDA213535, NDA219285 |
| Active ingredients (FDA) | RISDIPLAM |
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 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 →