Drug recall
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by…
FDA recall event 99385 · Class II · Ascend Laboratories, LLC
Key facts
| Event ID | 99385 |
|---|---|
| Recall numbers | D-0712-2026 |
| Recalling firm | Ascend Laboratories, LLC |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications |
| Initiation date | Jul 8, 2026 |
| Report date | Jul 29, 2026 |
| City | Bedminster |
| State | NJ |
| Country | United States |
| FEI number | 3004459274 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: