Class II
Ongoing
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
This recall is currently active, issued August 20, 2025. It was issued by Ascend Laboratories, Llc.
- Company
- Ascend Laboratories, Llc
- Recall Initiated
- July 21, 2025
- Posted
- August 20, 2025
- Recall Number
- D-0576-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8,568 bottles
- Firm Location
- Bedminster, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications: low dissolution results
Distribution
Nationwide in the USA
Lot / Code Info
Lot 23121560, Exp 4/30/2026
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