Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12 — Class III drug recall D-1570-2014
Terminated recall by Apotex Corp., reported 2014-09-24, distributed nationwide. Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
| Recall number | D-1570-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Corp., Weston, FL, United States |
| Recall initiated | 2014-08-21 |
| Classified | 2014-09-15 |
| Reported by FDA | 2014-09-24 |
| Terminated | 2019-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 1,494 bottles |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00360505375998 |
| NDC | 60505-3759-09 |
| Lot numbers | KK6086 |
| Expiration dates | 2015-03 |
Product
Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9
Reason for recall
Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
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-1570-2014. 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.