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

FDA recall notice · announced October 14, 2026 · J&j Innovative Medicine

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 for recall

Presence of particulate matter.

Notes

Distribution: OH
Lot/code information: Lot JNYJ1208; Exp. 10/30/2027
Quantity: 49 vials
Status: Ongoing
Products in this recall event:
- 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: (D-0016-2027)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.