Candesartan Cilexetil Tablets — Class III drug recall D-0659-2016
Terminated recall by Sandoz Inc, reported 2016-02-17, distributed nationwide. Failed Impurities/Degradation Specifications; 9 month stability timepoint
| Recall number | D-0659-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Inc, Princeton, NJ, United States |
| Recall initiated | 2015-12-31 |
| Classified | 2016-02-11 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2017-04-12 |
| Distributed | Nationwide (US) |
| Quantity | 277,267 bottles |
| Reason classes | specification failure |
| NDC | 00781-5938-31, 00781-5938-92 |
Product
Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540
Reason for recall
Failed Impurities/Degradation Specifications; 9 month stability timepoint
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-0659-2016. 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.