Mallinckrodt Hospital Products recall: Acthar Gel
Mallinckrodt Hospital Products Inc. is recalling Acthar Gel – 12367 vials. The U.S. Food and Drug Administration published the recall on September 2, 2026; it began on August 6, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Share
| Product | Acthar Gel |
| Brand | Mallinckrodt Hospital Products |
| Company | Mallinckrodt Hospital Products Inc. |
| Type | Drugs |
| Classification | Class II |
| Recall date | August 6, 2026 |
| Published by FDA | September 2, 2026 |
| Quantity | 12367 vials |
| Recall ID | 99570 |
Recalled products
- 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
- FDA recall number
- D-0803-2026
- Codes, lots and dates
- Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
- Quantity
- 12367 vials
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99570
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Bridgewater, NJ, United States
Why it was recalled
The reason the FDA lists: “Presence of particulate matter: glass and stopper piece”
Where it was sold
Nationwide. Distribution as the FDA records it: “USA Nationwide”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99570, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other drug recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 |  Ajanta Pharma recall: Ranolazine Extended-Release TabletsDrugs | Failed Dissolution Specifications: below specification Serious | FDA Class II |
| Oct 7, 2026 | Par Health recall: Buprenorphine HydrochlorideDrugs · 154210 bottles | Crystallization Serious | FDA Class II |
| Oct 7, 2026 | Apotex recall: Paroxetine Extended-Release TabletsDrugs | Failed dissolution specifications. Serious | FDA Class II |
| Oct 7, 2026 | TerSera Therapeutics recall: ZoladexDrugs · 296 cartons | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II |
| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is Mallinckrodt Hospital Products Acthar Gel recalled?
Yes. Mallinckrodt Hospital Products Inc. recalled it on August 6, 2026; FDA published it September 2, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Presence of particulate matter: glass and stopper piece
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.