FDA Drug recall D-0991-2018
Enalapril Maleate, USP 5MG, 90-count bottle, RX only
- FDA Drug
- Class III
- terminated
- Published 2018-08-01
On 2018-08-01 the FDA classified a Class III recall of Enalapril Maleate, USP 5MG, 90-count bottle, RX only by Aidarex Pharmaceuticals, citing out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0991-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-06-27 |
| Published | 2018-08-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aidarex Pharmaceuticals |
| Distribution | US |
Product
Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0693-90
Reason
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Identifiers
| code_info | Lots: 51904-1, EXP: 01/31/2018; 51904-4, 52885-1, EXP: 03/31/2018; 52885-3, EXP: 04/30/2018; 52885-4,EXP: 05/28/2018; 5…Lots: 51904-1, EXP: 01/31/2018; 51904-4, 52885-1, EXP: 03/31/2018; 52885-3, EXP: 04/30/2018; 52885-4,EXP: 05/28/2018; 53840-2,EXP: 5/28/2018; 53840-3, EXP:6/30/2018; 53840-4, EXP:8/31/2018; 56665-1, EXP: 01/31/2019; 58596-1, EXP: 05/28/2019. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0991-2018%22
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