Amlodipine and Olmesartan Medoxomil Tablets — Class II drug recall D-0576-2025
Ongoing recall by Ascend Laboratories, LLC, reported 2025-08-20, distributed nationwide. Failed Dissolution Specifications: low dissolution results
| Recall number | D-0576-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories, LLC, Bedminster, NJ, United States |
| Recall initiated | 2025-07-21 |
| Classified | 2025-08-08 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 8,568 bottles |
| Reason classes | specification failure |
| NDC | 67877-0499, 67877-0499-30, 67877-0499-90, 67877-0500, 67877-0500-30, 67877-0500-90, 67877-0501, 67877-0501-30, 67877-0501-90, 67877-0502, 67877-0502-30, 67877-0502-90 |
| Lot numbers | 23121560 |
| Expiration dates | 2026-04-30 |
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 for recall
Failed Dissolution Specifications: low dissolution results
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0576-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.