J&J INNOVATIVE MEDICINE recalls IMAAVY
- Recalling company
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Sep 23, 2026
- Reported
- Oct 14, 2026
- Distribution
- OH
- Status
- Ongoing
- Quantity
- 49 vials
- Lot / codes
- Lot JNYJ1208; Exp. 10/30/2027
- Company location
- Malvern, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0016-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0016-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.