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Class II · ModerateActive recall

Imaavy

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot JNYJ1208; Exp. 10/30/2027
Where it was soldOH
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of particulate matter.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byJanssen Biotech, Inc., Horsham, PA 19044
Brand nameIMAAVY
Generic nameNIPOCALIMAB-AAHU
Active ingredient(s)NIPOCALIMAB
Distributed by / forJ&J INNOVATIVE MEDICINE
NDC57894-800-01
Show the full FDA record
Full product labelIMAAVY (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
Recalling firmJ&J INNOVATIVE MEDICINE
DistributionOH
Quantity49 vials
Recall initiated2026-09-23
Report date2026-10-14
Recall completed—
Recall numberD-0016-2027
ClassificationClass II
FDA statusOngoing
Origin on fileMalvern PA United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.