Reported Aug 20, 2025 · Ongoing

Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories…

Ascend Laboratories, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ascend Laboratories, LLC · 135 Us Highway 202 206 Ste 15 · Bedminster, NJ · 07921-2608

Is this the product you have?

  • Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only
  • Manufactured byAlkem Laboratories Ltd., INDIA
  • Distributed byAscend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
Lot codes and dates
    • Lot 23121560
    • Exp 4/30/2026
Amount recalled
8,568 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications: low dissolution results

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.