Risperidone Oral Solution — Class III drug recall D-1299-2014
Terminated recall by Apotex Inc., reported 2014-05-07, distributed nationwide. Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability t
| Recall number | D-1299-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Inc., Toronto, Canada |
| Recall initiated | 2014-03-20 |
| Classified | 2014-05-01 |
| Reported by FDA | 2014-05-07 |
| Terminated | 2014-12-23 |
| Distributed | Nationwide (US) |
| Quantity | 11,422 bottles |
| Reason classes | specification failure |
| NDC | 60505-0380-01 |
| Lot numbers | 06/14, KD4855 |
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 for recall
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
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-1299-2014. 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.