Why it was recalled
Presence of particulate matter: glass and stopper piece
Product description
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
Lot numbers, UPCs & expiration codes
Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0803-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 6, 2026
- FDA report date
- Sep 2, 2026
- Quantity
- 12367 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mallinckrodt Hospital Products Inc.
Original FDA data
Every field from FDA enforcement report D-0803-2026, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99570
- Address
- 440 Us Highway 22 Ste 302
- Code information
- Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
- Postal code
- 08807-2477
- Report date
- Sep 2, 2026
- Product type
- Drugs
- Recall number
- D-0803-2026
- Classification
- Class II
- Recalling firm
- Mallinckrodt Hospital Products Inc.
- Product quantity
- 12367 vials
- Reason for recall
- Presence of particulate matter: glass and stopper piece
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Aug 6, 2026
- Initial firm notification
- Letter
- Center classification date
- Aug 26, 2026