Amlodipine and Olmesartan Medoxomil Tablets Recalled Due to Failed Dissolution Specifications

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for amlodipine and olmesartan medoxomil tablets, 10 mg/20 mg. The affected batch has been identified as Lot 25121311 (expires March 2028), affecting 6192 bottles.
• The recall was initiated by Ascend Laboratories, LLC due to failed dissolution specifications, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension.

The FDA has issued a Class II recall for amlodipine and olmesartan medoxomil tablets, 10 mg/20 mg, affecting 6192 bottles. This product is manufactured by Alkem Laboratories, Ltd based in India, and it is being recalled by Ascend Laboratories, LLC in Bedminster, New Jersey. The recall was initiated on July 8, 2026, and received a Class II classification on July 20, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to the product’s failure to meet dissolution specifications; specifically, the olmesartan medoxomil content is below required levels. This deficiency affects Lot 25121311, which will expire in March 2028. Ascend Laboratories sent out a public notice via letter; no press release has been issued for this recall.

Amlodipine and olmesartan medoxomil tablets are used to treat hypertension by lowering blood pressure. Pharmacists should identify and quarantine Lot 25121311, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. July 29, 2026. Accessed July 29, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221449