Recall: D-0712-2026

Class II - Potentially Harmful

Class IIClassification

2026-07-08Initiated

OngoingStatus

Ascend Laboratories, LLCFirm

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.