# FDA recall D-1134-2017

> **Ascend Laboratories LLC** · Class III · drug recall initiated 2017-05-05.

## 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.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-1134-2017
- **Recalling firm:** Ascend Laboratories LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-05-05
- **Report date:** 2017-09-20
- **Termination date:** 2018-04-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Montvale, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1134-2017

## Citation

> AI Analytics. FDA recall D-1134-2017. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/D-1134-2017. Source: US FDA. Licensed CC0.

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