D-0712-2026 Class II Ongoing
FDA drug recall D-0712-2026 was initiated by Ascend Laboratories, LLC on July 8, 2026 and is designated Class II. Reason for recall: Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications The recall status is ongoing. Affected quantity: 6,192 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 29, 2026
- Initiation Date
- July 8, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,192 bottles
Product Description
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
Reason for Recall
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Distribution Pattern
Nationwide in the USA
Code Information
Lot 25121311, expiry 3/31/2028