FDA Drug recall D-0820-2018
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
- FDA Drug
- Class II
- terminated
- Published 2018-05-23
On 2018-05-23 the FDA classified a Class II recall of Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01 by Mylan Pharmaceuticals, citing cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0820-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-24 |
| Published | 2018-05-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | n/a |
Product
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
Reason
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Identifiers
| code_info | Lot Numbers# 3083008 and 3086124, exp Jan 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-0820-2018%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.