FDA Drug recall D-0576-2025
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA
- FDA Drug
- Class II
- ongoing
- Published 2025-08-20
On 2025-08-20 the FDA classified a Class II recall of Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA by Ascend Laboratories, citing failed Dissolution Specifications: low dissolution results.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0576-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-21 |
| Published | 2025-08-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | US |
Product
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
Reason
Failed Dissolution Specifications: low dissolution results
Identifiers
| ndc | 67877-499-30 |
|---|---|
| ndc | 67877-499-90 |
| ndc | 67877-500-30 |
| ndc | 67877-500-90 |
| ndc | 67877-501-30 |
| ndc | 67877-501-90 |
| ndc | 67877-502-30 |
| ndc | 67877-502-90 |
| code_info | Lot 23121560, Exp 4/30/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0576-2025%22
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