Ascend Laboratories, Llc: Amlodipine And Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets
Recall Summary Ascend Laboratories is recalling Amlodipine and Olmesartan Medoxomil Tablets (10mg/40mg, 30-tablet bottles, NDC 67877-502-30) distributed nationwide because the tablets don't dissolve properly in the body as specified. This is a Class II recall, meaning use of the product could result in adverse health consequences. The affected medication was manufactured by Alkem Laboratories Ltd. in India and distributed to all U.S. states and Washington, D.C.
- Recalling firm
- Ascend Laboratories, LLC
- Product
- Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-502-30.
- Reason
- Out of specification due to dissolution.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-10-06
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the United States
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/7289ff81-e2e1-47ce-8dba-aabacfdcac03