FDAClass IIJune 10, 2026

Amlodipine and Olmesartan Medoxomil Tablets recall: Failed Dissolution

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.

Why was Amlodipine and Olmesartan Medoxomil Tablets recalled?

Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

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: 24123460, Expires: October 31, 2027.

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.
Recalling firm
Ascend Laboratories, LLC
Quantity
15,696 x 30's bottles
Distribution
U.S.A. Nationwide
Recall date
June 10, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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