FDA recall D-0556-2026

Product

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.

Reason for recall

Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

Distribution

U.S.A. Nationwide

Key facts

Status

Ongoing

Initiation date

2026-05-05

Report date

2026-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bedminster, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0556-2026