TFDA orders recall of heart drug tablets over impurities

Taipei, Aug. 29 (CNA) The Taiwan Food and Drug Administration (TFDA) has ordered the recall of 586,000 tablets of a heart medication because of impurities that could potentially affect its efficacy.

The recall of Biocor Film-Coated Tablets 5 mg, supplied by Anxo Pharmaceutical Co. and bearing batch number BCLA91, was announced by the TFDA on Wednesday.

TFDA official Liu Chia-ping (劉佳萍) told CNA on Saturday that the recall was ordered after the agency was notified by the supplier that impurity levels had reached the upper limit of specifications during recent stability testing, potentially affecting the drug's quality and efficacy.

Liu said the company was ordered to complete the recall by Aug. 31 and submit a recall report, along with corrective and preventive measures to avoid similar problems in the future.

The drug contains bisoprolol fumarate and is approved for the treatment of hypertension, angina and stable, moderate-to-severe chronic heart failure.

According to data from the National Health Insurance Administration, 750,151 tablets were dispensed through the National Health Insurance program in 2025.

Pharmaceutical companies that fail to conduct recalls as required by law can face fines ranging from NT$200,000 (US$6,317) to NT$5 million under the Pharmaceutical Affairs Act.

Liu said more than 10 other drugs with the same active ingredient, dosage form and strength are licensed in Taiwan, meaning there is no concern about a shortage.

People with concerns about their medication should consult their doctors as soon as possible about switching to an appropriate alternative, she added.