AMLODIPINE BESYLATE TABLET — Class III drug recall D-1134-2017
Terminated recall by Ascend Laboratories LLC, reported 2017-09-20, distributed nationwide. PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlo
| Recall number | D-1134-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories LLC, Montvale, NJ, United States |
| Recall initiated | 2017-05-05 |
| Classified | 2017-09-11 |
| Reported by FDA | 2017-09-20 |
| Terminated | 2018-04-25 |
| Distributed | Nationwide (US) |
| Quantity | 1,212 bottles |
| Reason classes | labeling |
| NDC | 67877-0197, 67877-0197-05, 67877-0197-10, 67877-0197-38, 67877-0197-90, 67877-0198, 67877-0198-05, 67877-0198-10, 67877-0198-38, 67877-0198-90, 67877-0199, 67877-0199-05, 67877-0199-10, 67877-0199-38, 67877-0199-90 |
| Lot numbers | 09/19, 6142626 |
Product
AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC Montvale, NJ 07645, NDC 67877-199-10
Reason for recall
PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
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-1134-2017. 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.