FDAFDA · Food and drugs·Recall number D-0576-2025
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
Published August 20, 2025 · Recall initiated: July 21, 2025
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: low dissolution results
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 23121560, Exp 4/30/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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