J&J Innovative Medicine Imaavy Injection
Imaavy (nipocalimab-aahu) Injection contains particulate matter.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
J&J Innovative Medicine is recalling IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, for intravenous infusion after dilution, because of the presence of particulate matter. The recall, which began on September 23, 2026, involves 49 vials manufactured by Janssen Biotech, Inc., Horsham, PA 19044, and was added to the FDA's Enforcement Report on October 8, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
IMAAVY (nipocalimab-aahu) Injection
- NDC
- 57894-800-01
- Lot
- JNYJ1208
Details
- Company began the recall
- Event ID
- 99972
- Company
- J&J INNOVATIVE MEDICINE
- Hazard
- Foreign material
- Quantity recalled
- 49 vials
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
