Amlodipine and Olmesartan Medoxomil Tablets recall (Ascend Laboratories, LLC)
DrugClass IIOngoing
Summary: Ascend Laboratories, LLC is recalling Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.. Reason: Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications.
What is being recalled
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.
Why
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S.A. Nationwide
How to tell if yours is affected
Lot: 24123460, Expires: October 31, 2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0556-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 5, 2026 |
| Reported | June 10, 2026 |
| Company | Ascend Laboratories, LLC |
| Company location | Bedminster, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 15,696 x 30's bottles |
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