Ascend Laboratories recalls amlodipine and olmesartan tablets over low olmesartan content
The 10 mg/20 mg tablets failed dissolution specifications and contain less olmesartan medoxomil than they should, and 6,192 bottles were sold nationwide in the USA.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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
- Company
- Ascend Laboratories, LLC
- Hazard
- Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
- Units
- 6,192 bottles
- Where sold
- Nationwide in the USA
- FDA classification
- Class II · Ongoing
- Classified by FDA
- July 20, 2026
- Recall started
- July 8, 2026
- FDA enforcement report
- July 29, 2026
- Identifiers
- Codes: Lot 25121311, expiry 3/31/2028
- FDA recall number: D-0712-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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
- Reason for recall
- Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide in the USA
- Quantity
- 6,192 bottles
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