Class II · ModerateActive recall
Acthar
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot#: NDC [redacted-phone]-1 - [redacted-phone], exp 1/31/2027 NDC [redacted-phone]-2 - 1564-107H, exp 1/31/2027
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Presence of particulate matter: glass and stopper piece
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byMallinckrodt ARD LLC
| Brand name | ACTHAR |
| Generic name | REPOSITORY CORTICOTROPIN |
| Active ingredient(s) | CORTICOTROPIN |
| Distributed by / for | Mallinckrodt Hospital Products Inc. |
| NDC | 63004-8710-1 |
Show the full FDA record
| Full product label | 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 firm | Mallinckrodt Hospital Products Inc. |
| Distribution | USA Nationwide |
| Quantity | 12367 vials |
| Recall initiated | 2026-08-06 |
| Report date | 2026-09-02 |
| Recall completed | — |
| Recall number | D-0803-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Bridgewater NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.