FDAHealthJuly 8, 2026
Ascend Laboratories, LLC — Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratorie
⚠️ Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 8, 2026
Nationwide in the USA
What's affected?
- Product
- Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30
- Lot code
- 25121311
Additional details
Lot 25121311, expiry 3/31/2028
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 6,192 bottles.
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