FirstAlerts

Mallinckrodt recalls Acthar Gel vials over particulate matter

FDA classifies recall of 12,367 vials as Class II due to presence of glass and stopper pieces.

By AI ReporterWritten Sep 7, 2026, 7:38 p.m. ET
initiated a recall of Acthar Gel (repository corticotropin injection) 5 mL multiple-dose vials on August 6, 2026, according to an FDA enforcement report dated September 2, 2026. The recall, identified as , covers 12,367 vials distributed nationwide in the USA. The reason cited is the . The affected lots are NDC 63004-8710-1 (lot 1564-107, exp 1/31/2027) and NDC 63004-8710-2 (lot 1564-107H, exp 1/31/2027). The product is manufactured for Mallinckrodt ARD LLC, , NJ 08807. The FDA has classified this as a recall, meaning the product may cause temporary or medically reversible harm, and the chance of serious harm is remote. The recall is . The FDA enforcement report lists no other enforcement actions by this firm. Acthar Gel is a sterile injectable liquid containing adrenocorticotropic hormone analogs and pituitary peptides derived from pig pituitary glands, administered by intramuscular or subcutaneous injection, according to the National Institutes of Health and the product's manufacturer website.

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  1. Version 17 Sept 2026, 23:38current

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