Taiwan FDA Clarifies Local Status After US Blood Pressure Medication Recall

The Taiwan Food and Drug Administration (TFDA) announced that a recent United States recall involving two batches of a triple-combination blood pressure medication does not affect the domestic market. The US Food and Drug Administration (FDA) issued a safety alert on October 26 regarding specific batches of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets due to dissolution test results failing to meet required specifications.

The affected medication in the United States, manufactured by Macleods Pharma USA, Inc., includes 40 mg/10 mg/12.5 mg tablets packaged in 30-count and 90-count bottles under batch numbers 12251163A and 12251163B. According to the US recall data, a total of 3,744 bottles were slated for a Class II recall because they did not pass standard dissolution testing parameters.

Following the US announcement, the TFDA conducted an internal review of domestic drug licenses and confirmed that a related product, "Macleods Film-Coated Tablets 40/10/12.5 mg," holds a valid license in Taiwan under license number 028932, with Genovate Biotechnology Co., Ltd. listed as the applicant. The primary active ingredients—olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide—are formulated to treat hypertension in patients who cannot achieve adequate blood pressure control using only two of these components.

TFDA Drug Division Senior Technical Specialist Liu Chia-ping stated that the applicant company verified that the specific medication has not yet been imported or distributed for sale in Taiwan. Consequently, the recalled batches from the United States have not entered the domestic market, and local medical supplies remain entirely unaffected.

The combination medication is a prescription drug that requires a physician's diagnosis and prescription before use. Health officials stressed that multi-ingredient blood pressure formulations help reduce daily pill burdens for patients managing chronic hypertension, but individuals should continue their prescribed regimens strictly under medical supervision.

To address consumer concerns, the TFDA published the relevant safety alert details on its official website under the "Domestic Consumer Traffic Light - International Drugs" section, assigning it a yellow warning light. Authorities urged patients not to panic or stop taking their prescribed medications based on overseas recall reports, and advised consumers against attempting to purchase the recalled products through unauthorized foreign websites or overseas channels.