Risperdal CONSTA
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
Recall notice
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
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We’re still writing up this recall
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
Source Page by GovInfoNow · govinfonow.com/recall/46617-janssen-pharmaceuticals-inc-recalls-risperdal-consta-risperidone-25-mg-dose · Recall date September 11, 2013 · FDA enforcement record: FDA #D-1514-2014
Cite this page
“Risperdal CONSTA.” GovInfoNow, recall dated September 11, 2013. https://govinfonow.com/recall/46617-janssen-pharmaceuticals-inc-recalls-risperdal-consta-risperidone-25-mg-dose. Based on FDA recall #D-1514-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1514-2014%22&limit=1).
How to tell if you have this one
- Brand
Janssen Pharmaceuticals, Inc.- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-1514-2014 (September 11, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1514-2014 to see it in context.
- 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.