Ascend Recalls 11,424 Bottles of Amlodipine and Olmesartan Tablets Over Dissolution Failure, an FDA Class II Recall
Ascend Laboratories is recalling its amlodipine and olmesartan medoxomil tablets (10 mg/40 mg), a total of 11,424 bottles, because the product failed dissolution specifications, meaning it does not release its active ingredients at the proper rate and may not lower blood pressure as expected, according to the Food and Drug Administration's enforcement records. The FDA classified the recall as Class II, dated October 16.
The recall covers a single lot: 30-count bottles with National Drug Code (NDC) 67877-502-30, lot 25120696, expiring December 31, 2026. The tablets were manufactured by Alkem Laboratories in India.
Amlodipine and olmesartan are both widely used blood pressure medicines, and the combination tablet is a generic version of the brand-name drug Azor. The brand-name product is not part of this recall.
Under the FDA's classification, a Class II recall means use of the product may cause temporary or medically reversible adverse health consequences, while the probability of serious health problems is low. Patients taking the generic can check the NDC and lot number on their bottle labels to see whether their medication is included.
It is the latest in a run of blood pressure combination tablets recalled over dissolution failures in the FDA's October enforcement records; a triple-combination tablet from Macleods was classified Class II for the same reason earlier in the season.
(Source: U.S. Food and Drug Administration Enforcement)
Source: U.S. Food and Drug Administration Enforcement
Published by GSM · USA (original Chinese edition)
Photo: 泡罩包装中的药片（资料图）。佚名 摄，CC0，经 Wikimedia Commons。 / Tablets in a blister pack (file photo). Photo: unknown, CC0, via Wikimedia Commons.
