CLASS II ONGOING Drug recall · Reported 28 Feb 2024 · FDA Enforcement Report
Acthar Gel (repository corticotropin injection) recalled
Mallinckrodt Hospital Products is recalling Acthar Gel (repository corticotropin injection) 400 USP units/ (80 USP units/mL), distributed nationwide in the US. The recall was initiated on 6 Feb 2024 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-0340-2024
- FDA event ID
- 93945
- Recalling firm
- Mallinckrodt Hospital Products, Bridgewater, NJ
- Brand
- Acthar
- Manufacturer
- Mallinckrodt ARD LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Feb 2024
- FDA classified
- 21 Feb 2024
- Reported
- 28 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Feb 2024 | Recall initiated by company | |
| 21 Feb 2024 | Classified by FDA | +15 days |
| 28 Feb 2024 | 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
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Product as listed by the FDA
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
Where it was distributed
USA nationwide
Questions about this recall
Why was it recalled?
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Which lots are affected?
Lot #: 1564-103, Exp 9/30/2024
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.
Other products in this recall event
1 other product · FDA event 93945This product is part of a recall event; the main page for the event is Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial recalledTerlivaz | Mallinckrodt Hospital Products | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Mallinckrodt Hospital Products
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acthar Gel (repository corticotropin injection) multiple-dose vial recalledActhar | Mallinckrodt Hospital Products | Particulate Matter | 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) multiple-dose vial recalledActhar | Mallinckrodt Hospital Products | Particulate Matter | Nationwide |