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.
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