FDAFDA · Food and drugs·Recall number D-0712-2026
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
Published July 29, 2026 · Recall initiated: July 8, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Manufacturer
- Ascend Laboratories, LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot 25121311, expiry 3/31/2028
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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