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TemporaryFDAOngoing

Can cause harm that is usually temporary. Speak to your pharmacist or doctor — do not stop a prescribed medicine on your own.

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

Check the label for

Lot JNYJ1208; Exp. 10/30/2027
Why
Presence of particulate matter.
Distributed
OH
Company
J&J INNOVATIVE MEDICINE
Announced
This is the date the recall was announced. A company may have started it weeks earlier.
Recall began

Already ate or took it and feel unwell? Call Poison Control — 1-800-222-1222

Source: FDA record D-0016-2027 · retrieved 8 October 2026

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