FDA Drug recall D-0257-2015
Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd
- FDA Drug
- Class III
- terminated
- Published 2014-12-03
On 2014-12-03 the FDA classified a Class III recall of Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd by Zydus Pharmaceuticals Usa, citing discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0257-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-10-01 |
| Published | 2014-12-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
Product
Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16
Reason
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Identifiers
| ndc | 68382-121-01 |
|---|---|
| ndc | 68382-121-05 |
| ndc | 68382-121-16 |
| ndc | 68382-121-77 |
| ndc | 68382-122-16 |
| ndc | 68382-122-01 |
| ndc | 68382-122-05 |
| ndc | 68382-122-77 |
| ndc | 68382-123-16 |
| ndc | 68382-123-01 |
| ndc | 68382-123-05 |
| ndc | 68382-123-77 |
| code_info | Lot #: MP4344, Exp 04/2016 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0257-2015%22
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