CLASS II ONGOING Drug recall · Reported 2 Sep 2026 · FDA Enforcement Report
Acthar Gel (repository corticotropin injection) multiple-dose vial recalled
Mallinckrodt Hospital Products is recalling Acthar Gel (repository corticotropin injection) multiple-dose vial, distributed nationwide in the US. The recall was initiated on 6 Aug 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0803-2026
- FDA event ID
- 99570
- Recalling firm
- Mallinckrodt Hospital Products, Bridgewater, NJ
- Brand
- Acthar
- Manufacturer
- Mallinckrodt ARD LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Aug 2026
- FDA classified
- 26 Aug 2026
- Reported
- 2 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Aug 2026 | Recall initiated by company | |
| 26 Aug 2026 | Classified by FDA | +20 days |
| 2 Sep 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of particulate matter: glass and stopper piece
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Presence of particulate matter: glass and stopper piece
Which lots are affected?
Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mallinckrodt Hospital Products
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acthar Gel (repository corticotropin injection) recalledActhar | Mallinckrodt Hospital Products | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial recalledTerlivaz | Mallinckrodt Hospital Products | Manufacturing (CGMP) Deviations | Nationwide |
Other Repository Corticotropin recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acthar Gel (repository corticotropin injection) recalledActhar | Mallinckrodt Hospital Products | Manufacturing (CGMP) Deviations | Nationwide |