FDAFDA · Food and drugs·Recall number D-0556-2026
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.
Published June 10, 2026 · Recall initiated: May 5, 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
- U.S.A. Nationwide
- Lot
- Lot: 24123460, Expires: October 31, 2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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