Candesartan Cilexetil Tablets — Class III drug recall D-0329-2021
Terminated recall by Macleods Pharma Usa Inc, reported 2021-04-21, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0329-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Macleods Pharma Usa Inc, Plainsboro, NJ, United States |
| Recall initiated | 2021-03-22 |
| Classified | 2021-04-12 |
| Reported by FDA | 2021-04-21 |
| Terminated | 2022-12-13 |
| Distributed | Nationwide (US) |
| Quantity | 8,015 packages |
| Reason classes | specification failure |
| NDC | 33342-0114, 33342-0114-07, 33342-0114-10, 33342-0114-12, 33342-0114-51, 33342-0115, 33342-0115-07, 33342-0115-10, 33342-0115-12, 33342-0115-51, 33342-0116, 33342-0116-07, 33342-0116-10, 33342-0116-12, 33342-0116-51, 33342-0117, 33342-0117-07, 33342-0117-10, 33342-0117-12, 33342-0117-51 |
| Lot numbers | ECD5908C, ECD5909A, ECD5910A, ECD5911A, ECD5912A |
| Expiration dates | 2021-07, 2021-09 |
Product
Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-10
Reason for recall
Failed Impurities/Degradation Specifications
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-0329-2021. 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.