CLASS II ONGOING Drug recall · Reported 14 Oct 2026 · FDA Enforcement Report
Imaavy (nipocalimab-aahu) Injection, 300 mg recalled
J&J Innovative Medicine is recalling Imaavy (nipocalimab-aahu) Injection, 300 mg / (185 mg/mL) per single-dose vial, For, distributed in Ohio. The recall was initiated on 23 Sep 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0016-2027
- FDA event ID
- 99972
- Recalling firm
- J&J Innovative Medicine, Malvern, PA
- Brand
- Imaavy
- Manufacturer
- Janssen Biotech, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Sep 2026
- FDA classified
- 8 Oct 2026
- Reported
- 14 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 23 Sep 2026 | Recall initiated by company | |
| 8 Oct 2026 | Classified by FDA | +15 days |
| 14 Oct 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of particulate matter.
Product as listed by the FDA
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
Where it was distributed
OH
Questions about this recall
Why was it recalled?
Presence of particulate matter.
Which lots are affected?
Lot JNYJ1208; Exp. 10/30/2027
Where was it sold?
OH
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.