Repository Corticotropin Injection Recalled Due to the Presence of Particulate Matter
Key Takeaways:
- The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for Acthar Gel (repository corticotropin) injection, 5 mL. The affected batches have been identified as Lots 63004-8710-1-1564-107 and 63004-8710-2-1564-107H (expiring January 2027), containing 12 367 vials.
- The recall was initiated by Mallinckrodt Hospital Products, Inc due to the presence of particulate matter, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
- Repository corticotropin injection is used to treat a variety of inflammatory and autoimmune disorders.
The FDA has issued a Class II recall for Acthar Gel (repository corticotropin) injection, 5 mL, affecting 12 367 vials. This product is manufactured and is being recalled by Mallinckrodt Hospital Products, Inc based in Bridgewater, New Jersey. The recall was initiated on August 6, 2026, and received a Class II classification on August 26, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
The recall was initiated after the firm discovered particulate matter—glass and stopper pieces—in the product. This deficiency affects Lots 63004-8710-1-1564-107 and 63004-8710-2-1564-107H, which will expire in January 2027. Mallinckrodt Hospital Products sent out a public notice via letter; no press release has been issued for this recall.
Repository corticotropin injection is used to treat multiple sclerosis, lupus, and polymyositis. It is also used for many joint conditions, including psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis, as well as certain allergic reactions such as Stevens-Johnson syndrome and serum sickness. Pharmacists should identify and quarantine Lots 63004-8710-1-1564-107 and 63004-8710-2-1564-107H, remove them from inventory, and coordinate with prescribers to provide an alternative supply.
Reference
FDA. Enforcement Report. September 2, 2026. Accessed September 2, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221891
