Amlodipine and Olmesartan Medoxomil Tablets recall (Ascend Laboratories, LLC)
DrugClass IIOngoing
Summary: Ascend Laboratories, LLC is recalling Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-502-30.. Reason: Out of specification due to dissolution.
What is being recalled
Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-502-30.
Why
Out of specification due to dissolution.
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
Nationwide within the United States
How to tell if yours is affected
Lot # 25120696, Exp Date: December 31, 2026.
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-0045-2027 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | October 6, 2026 |
| Reported | October 28, 2026 |
| Company | Ascend Laboratories, LLC |
| Company location | Bedminster, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 11,424 bottles. |
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