FDA Drug recall D-0329-2021
Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Man…
- FDA Drug
- Class III
- terminated
- Published 2021-04-21
On 2021-04-21 the FDA classified a Class III recall of Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Man… by Macleods Pharma Usa, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0329-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-03-22 |
| Published | 2021-04-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Macleods Pharma Usa |
| Distribution | US |
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
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 33342-114-07 |
|---|---|
| ndc | 33342-114-51 |
| ndc | 33342-114-12 |
| ndc | 33342-114-10 |
| ndc | 33342-115-07 |
| ndc | 33342-115-51 |
| ndc | 33342-115-12 |
| ndc | 33342-115-10 |
| ndc | 33342-116-07 |
| ndc | 33342-116-51 |
| ndc | 33342-116-12 |
| ndc | 33342-116-10 |
| ndc | 33342-117-07 |
| ndc | 33342-117-51 |
| ndc | 33342-117-12 |
| ndc | 33342-117-10 |
| code_info | Lots # : ECD5908C, Exp 7/2021; ECD5909A, ECD5910A, ECD5911A, ECD5912A, Exp. 09/2021. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0329-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.