Class II

Drug Recall: 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 · May 5, 2026

Reason for Recall

Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

Product Description

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 67877-501-30.

Distribution

U.S.A. Nationwide

States Affected

NATIONWIDE

Quantity Affected

15,696 x 30's bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0556-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.