Candesartan Cilexetil Tablets — Class III drug recall D-0243-2015
Terminated recall by Apotex Inc., reported 2014-11-12, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD
| Recall number | D-0243-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Inc., Toronto, N/A, Canada |
| Recall initiated | 2014-10-16 |
| Classified | 2014-11-06 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2016-09-30 |
| Distributed | Nationwide (US) |
| Quantity | 11,062 bottles |
| Reason classes | specification failure |
| NDC | 60505-3620-03, 60505-3620-09 |
Product
Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
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-0243-2015. 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.