Candesartan Cilexetil and Hydrochlorothiazide Tablets — Class III drug recall D-0049-2021
Terminated recall by Mylan Pharmaceuticals Inc., reported 2020-10-28, distributed nationwide. Out-of-specification organic impurity results obtained during routine stability testing.
| Recall number | D-0049-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2020-10-02 |
| Classified | 2020-10-22 |
| Reported by FDA | 2020-10-28 |
| Terminated | 2022-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 10,695 bottles |
| Reason classes | specification failure |
| NDC | 00378-3001, 00378-3001-77, 00378-3002, 00378-3002-05, 00378-3002-77, 00378-3003, 00378-3003-77 |
| Expiration dates | 2021-07-20 |
Product
Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Reason for recall
Out-of-specification organic impurity results obtained during routine stability testing.
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-0049-2021. 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.