IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Di
Summary
The FDA issued a Class II for IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose by J&J INNOVATIVE MEDICINE. Reason: Presence of particulate matter..
Details
Source
Drug Recall
External ID
D-0016-2027
Action Date
2026-10-14
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot JNYJ1208; Exp. 10/30/2027
Quantity Affected: 49 vials
Reason for Recall
Presence of particulate matter.
Distribution
OH
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-23
Company
Malvern, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 67 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (J&J INNOVATIVE MEDICINE) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does J&J INNOVATIVE MEDICINE have FDA actions?
This is the only FDA action we have on record for J&J INNOVATIVE MEDICINE in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0016-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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