candesartan cilexetil — Class III drug recall D-0288-2015
Terminated recall by Sandoz, Inc, reported 2014-12-10, distributed nationwide. Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 mo
| Recall number | D-0288-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz, Inc, Princeton, NJ, United States |
| Recall initiated | 2014-10-02 |
| Classified | 2014-12-02 |
| Reported by FDA | 2014-12-10 |
| Terminated | 2015-07-23 |
| Distributed | Nationwide (US) |
| Quantity | 6,336 bottles |
| Reason classes | specification failure |
| NDC | 00781-5938-92 |
| Lot numbers | 3007330 |
| Expiration dates | 2014-11 |
Product
candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92
Reason for recall
Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity 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-0288-2015. 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.