Official recall notice

FDA DrugClass IINotable

FDA Recall: Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinc

Recall date
2026-09-02
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Presence of particulate matter: glass and stopper piece

Product description

Presence of particulate matter: glass and stopper piece

Affected products

Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027

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