IMAAVY recall (J&J INNOVATIVE MEDICINE)
DrugClass IIOngoing
Summary: J&J INNOVATIVE MEDICINE is recalling 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.
What is being recalled
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
Why
Presence of particulate matter.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
OH
How to tell if yours is affected
Lot JNYJ1208; Exp. 10/30/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0016-2027 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 23, 2026 |
| Reported | October 14, 2026 |
| Company | J&J INNOVATIVE MEDICINE |
| Company location | Malvern, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 49 vials |
More recalls from J&J INNOVATIVE MEDICINE · all drug recalls · recalls from September 2026