ENALAPRIL MALEATE Tablets — Class III drug recall D-0053-2018
Terminated recall by Aidarex Pharmaceuticals LLC, reported 2017-11-01, distributed in FL. Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out
| Recall number | D-0053-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aidarex Pharmaceuticals LLC, Corona, CA, United States |
| Recall initiated | 2017-09-05 |
| Classified | 2017-10-26 |
| Reported by FDA | 2017-11-01 |
| Terminated | 2017-12-01 |
| Distributed | FL |
| Quantity | 12 bottles |
| Reason classes | specification failure |
| NDC | 33261-0693-90 |
| Lot numbers | 55097-2, 56085-1 |
| Expiration dates | 2018-11-30 |
Product
ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
Reason for recall
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results 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-0053-2018. 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.