Acthar Gel (repository corticotropin injection) recall
FDA recall D-0803-2026 · initiated Aug 6, 2026
Mallinckrodt Hospital Products Inc. recalled Acthar Gel (repository corticotropin injection) in Aug 2026 — an FDA Class II recall (D-0803-2026) because Presence of particulate matter: glass and stopper piece.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of particulate matter: glass and stopper piece
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 12367 vials
Details
- Product
- 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
- Recalling company
- Mallinckrodt Hospital Products Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Aug 6, 2026
- FDA report date
- Sep 2, 2026
This recall is linked to a product we cover: Acthar Gel (Autoinjector) →
Frequently asked
- Was Acthar Gel (repository corticotropin injection) recalled?
- Mallinckrodt Hospital Products Inc. recalled Acthar Gel (repository corticotropin injection) in Aug 2026 — an FDA Class II recall (D-0803-2026) because Presence of particulate matter: glass and stopper piece. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Acthar Gel (repository corticotropin injection) recalled?
- Per the FDA enforcement record, the reason for recall D-0803-2026 was: Presence of particulate matter: glass and stopper piece
- Is a recalled Acthar Gel (repository corticotropin injection) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Acthar Gel (repository corticotropin injection) are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0803-2026.