Nipocalimab Recall: Janssen Biotech Lot JNYJ1208
Announced 2026-10-14 · FDA
FDA recalls Nipocalimab-aahu injection lot JNYJ1208 (Exp. 10/30/2027), with 49 vials distributed in Ohio. The recall is due to the presence of particulate matter. Corrective action details are not provided in the available data.
| Brand | 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. |
| Severity | moderate |
| Units affected | 49 |
| Distribution | OH |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any Nipocalimab-aahu injection from lot JNYJ1208 or any product matching the lot/expiration.
- Contact your healthcare provider or the pharmacy for guidance and possible replacement or return.
- If you have the affected product, isolate it and follow disposal or recall instructions provided by your clinician or supplier.
- Check the FDA recall notice for updates and additional instructions.
How to identify the recalled item
| Lot / date codes | Lot JNYJ1208; Exp. 10/30/2027 |
|---|---|
| Lot / date codes | Lot JNYJ1208; Exp. 10/30/2027 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.