FDA recall D-0712-2026

Product

Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30

Reason for recall

Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2026-07-08

Report date

2026-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bedminster, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0712-2026