FDA Drug recall D-0051-2018
Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangab…
- FDA Drug
- Class III
- terminated
- Published 2017-11-01
On 2017-11-01 the FDA classified a Class III recall of Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangab… by Wockhardt Usa, citing failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0051-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-08-22 |
| Published | 2017-11-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Wockhardt Usa |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Identifiers
| code_info | Lot # DR10635, EXP 05/2019; DR10636, EXP 05/2019. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0051-2018%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.