Macleods Pharma USA is recalling many bottles of a hypertension drug on a national scale after the drug failed to meet federal quality standards, the U.S. Food and Drug Administration (FDA) announced.
This New Jersey-based pharmaceutical company has decided to initiate a national recall on specific batches of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets, which are prescribed for hypertension, following testing in which it was found that the olmesartan component did not meet the dissolution standard, the FDA explained.
This recall affects 3,528 30-count bottles from batch 12251163A (NDC 33342-246-07) and 216 90-count bottles from batch 12251163B (NDC 33342-246-10). These two batches have an expiry date of May 31, 2027, and were distributed nationally between November 21, 2025, and April 27, 2026.
Dissolution testing refers to the way a drug disintegrates and releases its active ingredient. This can mean that either the drug is not as effective or the dose is wrong, which may lead to a temporary decrease in blood-pressure control, the company warned.
The recall was undertaken by Macleods on Oct. 7, while the FDA categorised the recall as Class II, which means that the use of the recalled item “may cause temporary or medically reversible adverse health consequences,” although the possibility of serious effects is low.
The recall comes after another recall in September when the company based in India, Inventia Healthcare, recalled 13,567 bottles of 25 milligram chlorthalidone tablets because the drug had also failed the test for dissolving.
It is recommended that customers look for the recalled lot numbers and National Drug Code on their prescription bottle and contact their pharmacist or doctor in case of any concerns.
