Enalapril Maleate — Class III drug recall D-0990-2018
Terminated recall by Aidarex Pharmaceuticals LLC, reported 2018-08-01, distributed nationwide. Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stabilit
| Recall number | D-0990-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aidarex Pharmaceuticals LLC, Corona, CA, United States |
| Recall initiated | 2018-06-27 |
| Classified | 2018-07-25 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2019-12-04 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 33261-0977-90 |
| Lot numbers | 56698-1, 56698-2 |
| Expiration dates | 2019-01-31, 2019-04-30 |
Product
Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90
Reason for recall
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
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-0990-2018. 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.