FDA Drug recall D-0725-2016
risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only
- FDA Drug
- Class III
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class III recall of risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only by Zydus Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: Out of specification for a known degradant.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0725-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-01-14 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
Product
risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.
Reason
Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
Identifiers
| code_info | Lot #: MP4967, Expiry: 04/2016. |
|---|
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-0725-2016%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.