FDA · Drugs · Wednesday, June 10

Amlodipine and Olmesartan Medoxomil Tablets recall

Ascend Laboratories, LLC recalled Amlodipine and Olmesartan Medoxomil Tablets on June 10, 2026 because of failed Dissolution Specifications: Olmesartan Medoxomil content below specifications. It was sold nationwide.

Why it was recalled

Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

What's recalled

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.

Quantity: 15,696 x 30's bottles

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company: Ascend Laboratories, LLC, Bedminster, NJ
Date: Wednesday, June 10
Severity: Class II
the product could cause temporary or reversible health problems.
Where sold: Nationwide
U.S.A. Nationwide
Status: Ongoing
Recall number: D-0556-2026
Source: U.S. Food and Drug Administration

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