FDA-Drug2026-10-16Class IICHEMICAL
Ascend Laboratories amlodipine/olmesartan tablets recalled for dissolution defect
What this means
Ascend Laboratories is recalling one lot of amlodipine and olmesartan medoxomil combination tablets (10mg/40mg) because they do not dissolve properly in the body. This means the medication may not work as intended. The affected lot was distributed nationwide.
- Check if your amlodipine/olmesartan tablets match lot #25120696 with expiration date December 31, 2026 (NDC 67877-502-30).
- Contact your pharmacist or doctor if you have this lot; do not stop taking your blood pressure medication without medical guidance.
- Your pharmacist can provide a replacement or alternative medication.
The agency's original wording
Hazard
Out of specification due to dissolution.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the United States
Affected count
11,424 bottles.
Manufactured in
135 Us Highway 202 206 Ste 15, Bedminster, New Jersey, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0045-2027More Ascend Laboratories recalls
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