Drug FDA Class II Ongoing Failed specifications

Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30

Ascend Laboratories, LLC Published Aug 20, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Ascend Laboratories, LLC or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Failed Dissolution Specifications: low dissolution results

Hazards

Failed Dissolution · primary

Affected products (1)

Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30

AMLODIPINE AND OLMESARTAN MEDOXOMIL · 8,568 bottles

NDC: 67877-499, 67877-500, 67877-501, 67877-502, 67877-499-30, 67877-499-90, 67877-500-30, 67877-500-90, 67877-501-30, 67877-501-90, 67877-502-30, 67877-502-90

Lot codes: 23121560

Code info: Lot 23121560, Exp 4/30/2026

Affected areas

Nationwide

Timeline

Initiated

Jul 21, 2025
Published

Aug 20, 2025

Recall number: D-0576-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.