Drug recall
IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous…
FDA recall event 99972 · Class II · J&J INNOVATIVE MEDICINE
Key facts
| Event ID | 99972 |
|---|---|
| Recall numbers | D-0016-2027 |
| Recalling firm | J&J INNOVATIVE MEDICINE |
| Product type | Drugs |
| 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Presence of particulate matter. |
| Initiation date | Sep 23, 2026 |
| Report date | Oct 14, 2026 |
| City | Malvern |
| State | PA |
| Country | United States |
| FEI number | 3036831011 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: