# Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 6 — FDA Safety Label Change

> Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

**Manufacturer:** Ascend Laboratories, LLC
**Date of action:** 20260610
**Canonical URL:** https://drugsmonitor.com/recall/0dc3e5a7-c5be-48c2-a33a-b5f005b5645e
**Last updated:** 2026-06-11

## Summary

Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 6 (Ascend Laboratories, LLC) — Safety Label Change on 20260610.

Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

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*Educational recall record from DrugsMonitor.com. Confirm details with FDA primary sources.*