FDA Drug recall D-1493-2016
Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc
- FDA Drug
- Class III
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class III recall of Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc by Lupin, citing CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1493-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-02-19 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Lupin |
| Distribution | n/a |
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
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Identifiers
| ndc | 68180-750-09 |
|---|---|
| ndc | 68180-751-09 |
| ndc | 68180-751-03 |
| ndc | 68180-751-17 |
| ndc | 68180-752-09 |
| ndc | 68180-752-03 |
| ndc | 68180-719-03 |
| ndc | 68180-719-09 |
| ndc | 68180-720-09 |
| ndc | 68180-720-03 |
| ndc | 68180-721-03 |
| ndc | 68180-721-09 |
| ndc | 68180-233-01 |
| ndc | 68180-233-02 |
| ndc | 68180-455-02 |
| ndc | 68180-455-01 |
| code_info | Lot #: G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, G304534, Exp. 4/2016 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1493-2016%22
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