Ascend Laboratories recalls amlodipine and olmesartan medoxomil tablets because they failed a dissolution test
The 10mg/40mg tablets, sold in 30-tablet bottles, were found to be out of specification due to dissolution, and 11,424 bottles were distributed nationwide within the United States.
What to do
The notice does not give instructions. Read the official notice for details.
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Recall details
- Product
- Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-502-30.
- Company
- Ascend Laboratories, LLC
- Hazard
- Out of specification due to dissolution.
- Units
- 11,424 bottles.
- Where sold
- Nationwide within the United States
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 16, 2026
- Recall started
- October 6, 2026
- FDA enforcement report
- October 28, 2026
- Identifiers
- Codes: Lot # 25120696, Exp Date: December 31, 2026.
- FDA recall number: D-0045-2027
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, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-502-30.
- Reason for recall
- Out of specification due to dissolution.
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide within the United States
- Quantity
- 11,424 bottles.
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