FDA Drug recall D-1299-2014
Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for…
- FDA Drug
- Class III
- terminated
- Published 2014-05-07
On 2014-05-07 the FDA classified a Class III recall of Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for… by Apotex, citing failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1299-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-03-20 |
| Published | 2014-05-07 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Apotex |
| Distribution | US |
Product
Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.
Reason
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
Identifiers
| code_info | Lot #: KD4855, Exp 06/14 |
|---|
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-1299-2014%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.