Risperdal CONSTA — Class II drug recall D-1514-2014
Terminated recall by Janssen Pharmaceuticals, Inc., reported 2014-08-13, distributed nationwide. Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a
| Recall number | D-1514-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Janssen Pharmaceuticals, Inc., Titusville, NJ, United States |
| Recall initiated | 2013-09-11 |
| Classified | 2014-08-05 |
| Reported by FDA | 2014-08-13 |
| Terminated | 2015-01-23 |
| Distributed | Nationwide (US) |
| Quantity | 70,495 kits |
| Reason classes | sterility, specification failure |
| NDC | 50458-0306, 50458-0306-01, 50458-0306-11, 50458-0307, 50458-0307-01, 50458-0307-11, 50458-0308, 50458-0308-01, 50458-0308-11, 50458-0309, 50458-0309-01, 50458-0309-11 |
Product
Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11
Reason for recall
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1514-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.