FDA Drug · D-0016-2027

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

Class II · Ongoing

Presence of particulate matter.

Affected lots / codes — check yours against thisLot JNYJ1208; Exp. 10/30/2027

Recalling firm: J&J INNOVATIVE MEDICINE, Malvern, PA
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 49 vials
Distribution: OH
Recall initiated: September 23, 2026
Classified: October 8, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0016-2027%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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