Enalapril Maleate tablets — Class III drug recall D-0051-2018
Terminated recall by Wockhardt Usa Inc., reported 2017-11-01, distributed nationwide. Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for
| Recall number | D-0051-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wockhardt Usa Inc., Parsippany, NJ, United States |
| Recall initiated | 2017-08-22 |
| Classified | 2017-10-26 |
| Reported by FDA | 2017-11-01 |
| Terminated | 2019-02-27 |
| Distributed | Nationwide (US) |
| Quantity | 5,050 bottles |
| Reason classes | potency, specification failure |
| NDC | 64679-0924-03 |
| Lot numbers | DR10635, DR10636 |
| Expiration dates | 2019-05 |
Product
Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03;
Reason for recall
Failed Impurities/Degradation Specifications: 5mg strength being recalled for 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-0051-2018. 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.