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Drug FDA Class II Ongoing Failed specifications

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.

Ascend Laboratories, LLC Published Jun 10, 2026

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: Olmesartan Medoxomil content below specifications

Hazards

Failed Dissolution - Olmesartan Medoxomil Below Specification · primary

Affected products (1)

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.

AMLODIPINE AND OLMESARTAN MEDOXOMIL · 15,696 x 30's 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: 24123460
Code info: Lot: 24123460, Expires: October 31, 2027.

Affected areas

Nationwide

Timeline

  1. Initiated
    May 5, 2026
  2. Published
    Jun 10, 2026
Recall number
D-0556-2026
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.