J&j Innovative Medicine: Imaavy (nipocalimab-aahu) Injection, 300 Mg /1

Recall Summary J&J Innovative Medicine is recalling IMAAVY (nipocalimab-aahu) Injection, 300 mg vials, because the product contains particulate matter. This recall affects product distributed in Ohio and is classified as a Class II recall.

Recalling firm

J&J INNOVATIVE MEDICINE

Product

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

Reason

Presence of particulate matter.

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-09-23

Status

Ongoing

Areas affected

OH

Distribution

OH

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/3d7bdd3d-26a4-4463-99eb-6e48193cc84c