Amlodipine and Olmesartan Medoxomil Tablets recall
FDA recall D-0712-2026 · initiated Jul 8, 2026
Ascend Laboratories, LLC recalled Amlodipine and Olmesartan Medoxomil Tablets in Jul 2026 — an FDA Class II recall (D-0712-2026) because Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 6,192 bottles
Details
- 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
- Recalling company
- Ascend Laboratories, Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jul 8, 2026
- FDA report date
- Jul 29, 2026
Frequently asked
- Was Amlodipine and Olmesartan Medoxomil Tablets recalled?
- Ascend Laboratories, LLC recalled Amlodipine and Olmesartan Medoxomil Tablets in Jul 2026 — an FDA Class II recall (D-0712-2026) because Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Amlodipine and Olmesartan Medoxomil Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0712-2026 was: Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
- Is a recalled Amlodipine and Olmesartan Medoxomil Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Amlodipine and Olmesartan Medoxomil Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot 25121311, expiry 3/31/2028. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0712-2026.