FDA Drug recall D-1514-2014
Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-…
- FDA Drug
- Class II
- terminated
- Published 2014-08-13
On 2014-08-13 the FDA classified a Class II recall of Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-… by Janssen Pharmaceuticals, citing non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1514-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-11 |
| Published | 2014-08-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Janssen Pharmaceuticals |
| Distribution | US |
Product
Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11
Reason
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
Identifiers
| ndc | 50458-309-11 |
|---|---|
| ndc | 50458-309-01 |
| ndc | 50458-306-11 |
| ndc | 50458-306-01 |
| ndc | 50458-307-11 |
| ndc | 50458-307-01 |
| ndc | 50458-308-11 |
| ndc | 50458-308-01 |
| code_info | Vial - 4212AAP1, Kit - 309316, Exp. 07/15 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1514-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.