D-0556-2026 Class II Ongoing
FDA drug recall D-0556-2026 was initiated by Ascend Laboratories, LLC on May 5, 2026 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications The recall status is ongoing. Affected quantity: 15,696 x 30's bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 10, 2026
- Initiation Date
- May 5, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,696 x 30's bottles
Product Description
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.
Reason for Recall
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot: 24123460, Expires: October 31, 2027.