FDA Drug recall D-0053-2018
ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India
- 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, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India by Aidarex Pharmaceuticals, citing failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0053-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-09-05 |
| Published | 2017-11-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Aidarex Pharmaceuticals |
| Distribution | FL |
Product
ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
Reason
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Identifiers
| code_info | Lot #: 55097-2, 56085-1, Exp 11/30/2018 |
|---|
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-0053-2018%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.