IMAAVY Injection Recall: Particulate Matter Hazard
J&J recalls IMAAVY injection vials due to particulate matter. Check lot JNYJ1208, exp 10/30/2027 for details on this Class II drug recall.
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Presence of particulate matter.
What happened, in plain English
J&J Innovative Medicine is recalling a small batch of IMAAVY (nipocalimab-aahu) Injection due to the presence of particulate matter. The affected product consists of only 49 single-dose vials distributed in Ohio. No specific remedy or action steps are currently listed in the record. Read more at govinfonow.com/recall/1622876-j-j-innovative-medicine-recalls-imaavy-nipocalimab-aahu-injection-300.
Source Summary by GovInfoNow · govinfonow.com/recall/1622876-j-j-innovative-medicine-recalls-imaavy-nipocalimab-aahu-injection-300 · Updated October 21, 2026 · FDA enforcement record: FDA #D-0016-2027
Cite this page
“IMAAVY Injection Recall: Particulate Matter Hazard.” GovInfoNow, updated October 21, 2026. https://govinfonow.com/recall/1622876-j-j-innovative-medicine-recalls-imaavy-nipocalimab-aahu-injection-300. Based on FDA recall #D-0016-2027 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0016-2027%22&limit=1).
Why it’s dangerous
The presence of particulate matter in an injectable drug can pose serious health risks if the particles enter the bloodstream during intravenous infusion. This contamination violates standard safety expectations for sterile injections.
Who’s affected
Patients in Ohio who have been prescribed IMAAVY Injection and possess vials from lot JNYJ1208 with an expiration date of October 30, 2027. Healthcare providers administering this drug are also directly involved.
How to tell if you have this one
Check your vials for the following details: Brand IMAAVY, NDC 57894-800-01, Lot JNYJ1208, and Expiration Date 10/30/2027. The product is a 300 mg / 1.62 mL single-dose vial for intravenous infusion.
- Brand
J&J Innovative Medicine- Category
Drug
Where it went and when
Where it was distributed
Distributed in Ohio.
FDA distribution: “OH” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Ohio.
Recall timeline
FDA published this recall 21 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0016-2027 (September 23, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0016-2027 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.