FDA recall D-0576-2025

Product

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

Reason for recall

Failed Dissolution Specifications: low dissolution results

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-07-21

Report date

2025-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bedminster, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0576-2025