FDA Drugs recall ·
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg… recall
- Recall number
- D-0712-2026
- Date
- (initiated July 8, 2026)
- Company / brand
- Ascend Laboratories, LLC
135 Us Highway 202 206 Ste 15, Bedminster, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6,192 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot 25121311, expiry 3/31/2028
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0712-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.