Amlodipine Besylate and Benazepril HCl Capsules — Class II drug recall D-66403-010
Terminated recall by Mylan Pharmaceuticals Inc., reported 2013-11-13, distributed nationwide. CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured accord
| Recall number | D-66403-010 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2013-09-13 |
| Classified | 2013-11-04 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2015-07-23 |
| Distributed | Nationwide (US) |
| Quantity | 23,356 bottles |
| Reason classes | cgmp |
| NDC | 00378-6900-01 |
| Lot numbers | 2003188, 2003189, 2003190, 2003191, 3043498 |
Product
Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6900-01
Reason for recall
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
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-66403-010. 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.