FDAFDA recall D-0016-2027 · Oct 14, 2026
J&J INNOVATIVE MEDICINE: IMAAVY (nipocalimab-aahu) Injection recall
Recall found
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 for recall
Presence of particulate matter.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot JNYJ1208; Exp. 10/30/2027
- Quantity
- 49 vials
- Distribution
- OH
- Recalling firm
- J&J INNOVATIVE MEDICINE, Malvern, PA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-23
Source: openFDA enforcement record D-0016-2027 · search recall number D-0016-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.