FDA Drug recall D-0016-2027
IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Ma…
- FDA Drug
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Ma… by J And J Innovative Medicine, citing presence of particulate matter.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0016-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-09-23 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | J And J Innovative Medicine |
| Distribution | OH |
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.
Identifiers
| ndc | 57894-801-01 |
|---|---|
| ndc | 57894-800-01 |
| code_info | Lot JNYJ1208; Exp. 10/30/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0016-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.