J&j Innovative Medicine: Imaavy (nipocalimab-aahu) Injection, 300 Mg /1
IMAAVY Recall Summary Johnson & Johnson is recalling IMAAVY (nipocalimab-aahu) Injection 300 mg vials distributed in Ohio because the medication contains particulate matter. This is a Class II recall, meaning use of the product could cause serious adverse health consequences or death. The recall affects patients in Ohio who received this medication.
- Recalling firm
- J&J INNOVATIVE MEDICINE
- 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.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-09-23
- Status
- Ongoing
- Areas affected
- OH
- Distribution
- OH
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/6e9bb5db-4dd4-4a07-a119-2970456ba97a