FDA Drug recall D-0712-2026
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA
- FDA Drug
- Class II
- ongoing
- Published 2026-07-29
On 2026-07-29 the FDA classified a Class II recall of Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA by Ascend Laboratories, citing failed Dissolution Specifications; Olmesartan Medoxomil content below specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0712-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-08 |
| Published | 2026-07-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | US |
Product
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
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
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 25121311, expiry 3/31/2028 |
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-0712-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.