Reported Oct 14, 2026 · Ongoing · Updated Oct 20, 2026
IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After…
J&j Innovative Medicine
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: J&J INNOVATIVE MEDICINE · 200 Great Valley Pkwy · Malvern, PA · 19355-1307
Is this the product you have?
- IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only
- Manufactured byJanssen Biotech, Inc., Horsham, PA 19044
- NDC57894-800-01
- Lot codes and dates
Lot JNYJ1208Exp. 10/30/2027
- Amount recalled
- 49 vials
Where it was sold
Why it was recalled
Presence of particulate matter.
This product could cause temporary or reversible health problems — stop using it.
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