Amlodipine Besylate Tablets — Class II drug recall D-1466-2016
Terminated recall by Mylan Institutional, Inc. (d.b.a. UDL Laboratories), reported 2016-08-31, distributed nationwide. CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured accord
| Recall number | D-1466-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL, United States |
| Recall initiated | 2013-09-17 |
| Classified | 2016-08-23 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2018-04-24 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 51079-0450-20, 51079-0450-63 |
Product
Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
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-1466-2016. 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.