Candesartan Cilexetil Tablets — Class III drug recall D-0798-2021
Terminated recall by Viatris, reported 2021-09-22, distributed nationwide. Failed Impurities/Degradation Specifications; out of specification for Related Compound
| Recall number | D-0798-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Viatris, Morgantown, WV, United States |
| Recall initiated | 2021-09-13 |
| Classified | 2021-09-14 |
| Reported by FDA | 2021-09-22 |
| Terminated | 2022-04-28 |
| Distributed | Nationwide (US) |
| Quantity | 21,094 |
| Reason classes | specification failure |
| NDC | 00378-3224, 00378-3224-77, 00378-3224-93, 00378-3225, 00378-3225-77, 00378-3225-93, 00378-3231, 00378-3231-77, 00378-3231-93, 00378-3232, 00378-3232-77, 00378-3232-93 |
| Lot numbers | 3107334 |
| Expiration dates | 2021-10-20 |
Product
Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93
Reason for recall
Failed Impurities/Degradation Specifications; out of specification for Related Compound
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-0798-2021. 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.