FDAClass IIRecall started October 6, 2026

Amlodipine and Olmesartan Medoxomil Tablets 10 mg/40mg Recall: Failed Dissolution

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.

What is the FDA recall status?

The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.

How FDA enforcement data reports status

Why was Amlodipine and Olmesartan Medoxomil Tablets 10 recalled?

Out of specification due to dissolution.

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full product description

Which lot codes, UPCs or models are affected?

Lot # 25120696, Exp Date: December 31, 2026.

Agency record number: D-0045-2027
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.
Recalling firm: Ascend Laboratories, LLC
Quantity: 11,424 bottles.
Distribution: Nationwide within the United States
Recall started: October 6, 2026
Report date: October 28, 2026
Classification: Class II
Status: Ongoing
Agency: FDA (drug)

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