Recall: D-0576-2025

Class II - Potentially Harmful

Class IIClassification

2025-07-21Initiated

OngoingStatus

Ascend Laboratories, LLCFirm

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

Failed Dissolution Specifications: low dissolution results

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.