FDA-Drug2026-10-14Class IIPROCESSING DEFECT
J&J IMAAVY injection recalled for particulate matter contamination
What this means
A single lot of IMAAVY (nipocalimab-aahu) injection contains particulate matter that should not be present in the medication. This affects 49 vials distributed in Ohio. The contamination was detected before the medication reached patients.
- If you have IMAAVY with lot JNYJ1208 (expiration 10/30/2027), do not use it.
- Contact your pharmacy or healthcare provider immediately with the lot number.
- Your provider will arrange for a replacement vial or alternative treatment.
The agency's original wording
Hazard
Presence of particulate matter.
Intended for
Adults
Illnesses reported
None reported
Sold states
OH
Affected count
49 vials
Manufactured in
200 Great Valley Pkwy, N/A, Malvern, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0016-2027Want us to check the next one for you?
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