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
Presence of particulate matter.
| Recalling firm | J&J INNOVATIVE MEDICINE |
|---|---|
| Reason | Presence of particulate matter. |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Oct 14, 2026 |
| Initiated | Sep 23, 2026 |
| Region | PA, United States |
| Distribution | OH |
| Quantity | 49 vials |
| Code/Lot | Lot JNYJ1208; Exp. 10/30/2027 |
| Type | Voluntary: Firm initiated |
| Recall number | D-0016-2027 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: D-0016-2027)
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