Ascend Laboratories, Llc: Amlodipine And Olmesartan Medoxomil Tablets, 10 Mg/20 Mg, 30 Tablets Per Bottle

Recall Summary Ascend Laboratories is recalling Amlodipine and Olmesartan Medoxomil Tablets (10 mg/20 mg) in 30-tablet bottles nationwide because the tablets don't dissolve properly and contain less olmesartan medoxomil than specified. This combination medication is used to treat high blood pressure. The recall affects all states across the USA.

Recalling firm
Ascend Laboratories, LLC
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
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-07-08
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide in the USA

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/06ec4764-da06-43bf-98c8-563b40df09c1