Acthar Gel (Repository Corticotropin Injection) 5 mL Vials
Mallinckrodt recalls Acthar Gel 5 mL vials over glass and stopper particulate.
Consumers with the recalled vials should stop using them immediately and contact their healthcare provider or pharmacist for guidance. Return the product to the place of purchase or contact Mallinckrodt for a replacement or refund.
Recall at a glance
- Quantity recalled
- 12367 vials
Why it was recalled
Mallinckrodt Hospital Products is recalling Acthar Gel (repository corticotropin injection) 5 mL multiple-dose vials because they may contain particulate matter, including glass and stopper pieces.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx OnlyNDC / UPC: NDC 63004-8710-1, NDC 63004-8710-2
| Lot code |
|---|
| – |
| 63004-8710-1, 1564-107, 2027, 63004-8710-2, 1564-107H |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Foreign Material recalls
Editorial summary by Recall Canary · summary updated 2026-09-01 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification