Macleods Pharma USA is recalling thousands of bottles of a hypertension drug nationwide after it failed to meet federal quality standards, the U.S. Food and Drug Administration (FDA) announced. The New Jersey-based pharmaceutical company initiated the recall for specific batches of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide tablets after testing revealed that the olmesartan component failed to meet dissolution standards, the FDA explained.

The 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). Both batches carry an expiry date of May 31, 2027, and were distributed nationwide between November 21, 2025, and April 27, 2026.

Dissolution testing measures how a drug disintegrates and releases its active ingredient. The company warned that a failure in this process could mean the medication is less effective or improperly dosed, potentially leading to temporary fluctuations in blood pressure control.

Macleods initiated the recall on Oct. 7, and the FDA categorized it as Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences, though the risk of serious harm remains low. This follows a similar recall in September, when India-based Inventia Healthcare recalled 13,567 bottles of 25-milligram chlorthalidone tablets after they also failed dissolution testing.

Consumers are advised to check their prescription bottles for the recalled lot numbers and National Drug Code, and to consult their pharmacist or doctor if they have any concerns. Federal health regulators continue to monitor the retrieval process closely to ensure that all affected products are successfully removed from the supply chain across the United States.

Healthcare providers have also been alerted about the quality issue to prevent any further distribution or administration of the compromised medication batches to unsuspecting patients. The company maintains that patient safety remains its highest priority and is cooperating fully with regulatory authorities to resolve the manufacturing discrepancy swiftly and transparently.