Notice names this product. J&J INNOVATIVE MEDICINE’s IMAAVY (nipocalimab-aahu) Injection is named in FDA Class II recall D-0016-2027. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Presence of particulate matter. Identifying details: Lot JNYJ1208; Exp. 10/30/2027. Units affected: 49 vials. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Presence of particulate matter.
Company / brand: J&J INNOVATIVE MEDICINE recalls
Affected product: IMAAVY (nipocalimab-aahu) Injection recall status
Official ID D-0016-2027 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 12:00 PM UTC.