Quick answers
- What is Acthar?
- Acthar is a brand name of Repository corticotropin, a prescription medicine. The FDA NDC Directory lists 3 Acthar products in 3 strengths and forms.
- Who makes Acthar?
- Mallinckrodt Ireland holds the FDA application for Acthar (NDA008372, approved April 29, 1952).
- Is there a generic or store brand of Acthar?
- Yes. The FDA NDC Directory lists 4 other products with the same active ingredients, strength and form as a Acthar product. Ask your pharmacist whether one is right for you.
- Has Acthar been recalled?
- FDA enforcement reports list 2 recalls of Acthar products; the newest started August 6, 2026. A recall usually concerns specific lots, not every product.
What Acthar is
Each Acthar 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.
Repository corticotropin · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| corticotropin 40 USP units/0.5 mL injection (subcutaneous) | Acthar | None listed | — |
| corticotropin 80 USP units/mL injection (intramuscular, subcutaneous) | Acthar | 2 products, 1 company | — |
| corticotropin 80 USP units/mL injection (subcutaneous) | Acthar | 2 products, 1 company | — |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Repository corticotropin →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA008372 | Mallinckrodt Ireland | April 29, 1952 | 3 |
Companies that list Acthar
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Acthar products.
- Keenova ARD LLC3 products
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.
-
August 6, 2026 · Class II · Ongoing · D-0803-2026
Presence of particulate matter: glass and stopper piece
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2 — Mallinckrodt Hospital Products Inc.
-
February 6, 2024 · Class II · Ongoing · D-0340-2024
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 — Mallinckrodt Hospital Products Inc.
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.