Amlodipine and Benazapril HCL Capsules — Class II drug recall D-0819-2018
Terminated recall by Mylan Pharmaceuticals Inc., reported 2018-05-23. cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed acc
| Recall number | D-0819-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2018-04-24 |
| Classified | 2018-05-17 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2019-06-20 |
| Quantity | 25,488 bottles |
| Reason classes | cgmp |
| NDC | 00378-6896-01 |
| Lot numbers | 3083005, 3083006, 3086121, 3086122 |
| Expiration dates | 2019-01-20 |
Product
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
Reason for recall
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
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-0819-2018. 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.