Class IIReported 2025-08-20

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

Recalled by Ascend Laboratories, LLC

Reason for Recall

Failed Dissolution Specifications: low dissolution results

Recall Number

D-0576-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-07-21

Reported

2025-08-20

Distribution

Nationwide in the USA

Code Info

Lot 23121560, Exp 4/30/2026

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.