OVERLOOKED

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Class IIOngoing

J&J INNOVATIVE MEDICINE recalls IMAAVY (nipocalimab-aahu) Injection

Recall date · record updated Oct 14, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
J&J INNOVATIVE MEDICINE
Reason
Presence of particulate matter.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
OH
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99972…

Products

  1. 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

    Codes/lots: Lot JNYJ1208; Exp. 10/30/2027Quantity: 49 vialsRecall no. D-0016-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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