Amlodipine Besylate Tablets — Class III drug recall D-0257-2015
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2014-12-03, distributed nationwide. Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
| Recall number | D-0257-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2014-10-01 |
| Classified | 2014-11-21 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2016-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 15,144 bottles |
| NDC | 68382-0121, 68382-0121-01, 68382-0121-05, 68382-0121-16, 68382-0121-77, 68382-0122, 68382-0122-01, 68382-0122-05, 68382-0122-16, 68382-0122-77, 68382-0123, 68382-0123-01, 68382-0123-05, 68382-0123-16, 68382-0123-77 |
| Lot numbers | MP4344 |
| Expiration dates | 2016-04 |
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 for recall
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
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-0257-2015. 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.