Official recall notice

FDA DrugClass IINotable

IMAAVY Injection / per single-dose vial Recall (Oct 2026)

Product: IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044. NDC: 57894-800-01

Recall date
2026-10-14
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Presence of particulate matter.

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Product description

Presence of particulate matter.

Affected products

Lot JNYJ1208; Exp. 10/30/2027

Verify with the official notice →
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