Amlodipine Besylate Tablets USP — Class III drug recall D-1493-2016
Terminated recall by Lupin Limited, reported 2016-09-14. CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates fa
| Recall number | D-1493-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Limited, Verna, Salcette, Goa, India |
| Recall initiated | 2016-02-19 |
| Classified | 2016-09-06 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2017-04-03 |
| Quantity | 11,812 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 68180-0233, 68180-0233-01, 68180-0233-02, 68180-0455, 68180-0455-01, 68180-0455-02, 68180-0719, 68180-0719-03, 68180-0719-09, 68180-0720, 68180-0720-03, 68180-0720-09, 68180-0721, 68180-0721-03, 68180-0721-09, 68180-0750, 68180-0750-09, 68180-0751, 68180-0751-03, 68180-0751-09, 68180-0751-17, 68180-0752, 68180-0752-03, 68180-0752-09 |
| Lot numbers | G304532, G304533, G304534, G304535, G304536, G304537, G304538, G304539, G304540, G304541, G304545, G304677 |
| Expiration dates | 2016-04 |
Product
Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03
Reason for recall
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
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-1493-2016. 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.