FDAHealthJuly 21, 2025
Ascend Laboratories, LLC — 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
⚠️ Failed Dissolution Specifications: low dissolution results
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 21, 2025
Nationwide in the USA
What's affected?
- 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
- Lot code
- 23121560
Additional details
Lot 23121560, Exp 4/30/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 8,568 bottles.
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