Malvern, PA, United States
J&J INNOVATIVE MEDICINE recalls
1 recall recorded since 2018, most recently on 23 September 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 23 September 2026
- Reason
- Presence of particulate matter.
- Distribution
- OH
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044. NDC: 57894-800-01
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.