IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185… was recalled on September 23, 2026 in cooperation with the U.S. Food and Drug Administration because presence of particulate matter..
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
Lot JNYJ1208; Exp. 10/30/2027
Units affected: 49 vials
Where it was sold: OH
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Presence of particulate matter.
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: J&J INNOVATIVE MEDICINE
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed Content Uniformity Specifications
Failed Impurities/Degradation Specifications
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