Amlodipine Besylate Tablets — Class II drug recall D-1256-2015
Terminated recall by Wockhardt Usa Inc., reported 2015-07-29, distributed nationwide. CGMP Deviations: Firm did not adequately investigate customer complaints.
| Recall number | D-1256-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wockhardt Usa Inc., Parsippany, NJ, United States |
| Recall initiated | 2015-04-22 |
| Classified | 2015-07-17 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2018-05-09 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 64679-0423-01, 64679-0423-02 |
| Lot numbers | DM11422, DM11423, DM11424, DM11425, DM12634, DM12635, DM12660, DM12661, DM12662, DM12663, DM12673, DM12674, DM12684, DM12685, DM12975, DM12976, DM12977, DM12985, DM12986, DM13162, DM13163, DM13195, DM13196, DM13222, DM13223, DM13259, DM13269, DM13270, DM13271, DM13272, DM13273, DM13274, DM13275, DM13281, DM13282, DM13296, DM13297, DM13339, DM13341, DM13369 and 36 more |
| Expiration dates | 2015-05-31, 2015-09-30, 2015-10-31, 2015-11-30, 2015-12-31, 2016-02-29, 2016-03-31 |
Product
Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Reason for recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
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-1256-2015. 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.