Class IIDrug
Acthar Gel recall
Summary
Mallinckrodt Hospital Products Inc. is recalling Acthar Gel (repository corticotropin injection) (drug). According to the FDA report, the reason is: Presence of particulate matter: glass and stopper piece. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- Product
- 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
- Reason
- Presence of particulate matter: glass and stopper piece
- Lot / code info
- Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
- Quantity
- 12367 vials
- Distribution
- USA Nationwide
- Recalling company
- Mallinckrodt Hospital Products Inc., Bridgewater, NJ United States
- Recall started
- August 6, 2026
- FDA report date
- September 2, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0803-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Mallinckrodt Hospital Products Inc.) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.