Amlodipine and Olmesartan Medoxomil Tablets Recalled Due to Failure to Meet Dissolution Specifications
Key Takeaways:
- The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for amlodipine and olmesartan medoxomil tablets, 5 mg/40 mg. The affected batch has been identified as Lot 24123460 (expires October 2027), affecting 15 696 bottles.
- The recall was initiated by Ascend Laboratories, LLC due to failed dissolution specifications, a quality issue that may cause temporary or medically reversible adverse health consequences.
- Amlodipine and olmesartan medoxomil tablets are used to treat high blood pressure.
The FDA has issued a Class II recall for amlodipine and olmesartan medoxomil tablets, 5 mg/40 mg, affecting 15 696 bottles. This medication is manufactured by Alkem Laboratories Ltd in India and is distributed nationwide by Ascend Laboratories, LLC based in Parsippany, New Jersey. The recall was initiated by Ascend Laboratories on May 5, 2026, and received a Class II classification on June 2, 2026.
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 24123460, which will expire in October 2027. A Class II classification means the use of this product may cause temporary or medically reversible adverse health consequences, or it has a low probability of causing serious adverse health consequences. Ascend Laboratories sent out a public notice via letter; no public press release has been issued for this recall.
Amlodipine and olmesartan medoxomil tablets are prescribed to treat hypertension by relaxing blood vessels and increasing the supply of blood and oxygen to the heart. Pharmacists should identify and quarantine Lot 24123460, remove it from inventory, and coordinate with prescribers to provide an alternative supply.
Reference
FDA. Enforcement Report. June 10, 2026. Accessed June 10, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220060
