Amlodipine and Olmesartan Medoxomil Tablets recall: Failed Dissolution
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
Why was Amlodipine and Olmesartan Medoxomil Tablets recalled?
Failed Dissolution Specifications: low dissolution results
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 23121560, Exp 4/30/2026
- 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
- Recalling firm
- Ascend Laboratories, LLC
- Quantity
- 8,568 bottles
- Distribution
- Nationwide in the USA
- Recall date
- August 20, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)