D-0016-2027Class II

J&J INNOVATIVE MEDICINE

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2026-10-14

Distribution

Firm state

Product quantity

49 vials

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Environmental Monitoring

Reason for recall

Presence of particulate matter.

Product description

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

Code / lot info

Lot JNYJ1208; Exp. 10/30/2027

Other recalls SPEQ maps to Environmental Monitoring

2026-10-21Class IIHouston Rx LLC 2026-10-21Class IIHowmedica Osteonics Corp.2026-10-21Class IIHowmedica Osteonics Corp.2026-10-21Class IIMedtronic Sofamor Danek USA Inc

See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →