Ascend Laboratories, Llc: Amlodipine And Olmesartan Medoxomil Tablets, 5mg/40mg
Recall Summary Ascend Laboratories is recalling Amlodipine and Olmesartan Medoxomil Tablets (5mg/40mg) distributed nationwide because the olmesartan medoxomil content in the tablets is below the specified amount. This medication is used to treat high blood pressure, and the low drug content means it may not work as intended. The recall affects 30-count bottles with NDC number 67877-501-30 that were manufactured by Alkem Laboratories Ltd. in India.
- Recalling firm
- Ascend Laboratories, LLC
- Product
- Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.
- Reason
- Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-05
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S.A. Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/3454e52a-2ff0-43f1-80c0-211d08c837db