Recall
FDAHealthMay 5, 2026

Ascend Laboratories, LLC — Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC.,

⚠️ Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
May 5, 2026

U.S.A. Nationwide

What's affected?

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.
Lot code
24123460

Additional details

Lot: 24123460, Expires: October 31, 2027.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 15,696 x 30's bottles.

View original FDA notice →

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