Taipei: The Taiwan Food and Drug Administration (TFDA) has mandated the recall of 586,000 tablets of a heart medication due to impurities that could potentially impact its efficacy.
According to Focus Taiwan, the recall of Biocor Film-Coated Tablets 5 mg, supplied by Anxo Pharmaceutical Co. and identified by batch number BCLA91, was announced by the TFDA on Wednesday. TFDA official Liu Chia-ping informed CNA that the recall decision was made following a notification from the supplier. The notification indicated that impurity levels in the tablets had reached the upper limit of specifications during recent stability testing, which could potentially compromise the drug's quality and efficacy.
Liu further stated that the pharmaceutical company has been instructed to complete the recall process by August 31 and submit a detailed recall report. This report must include corrective and preventive measures to prevent future occurrences of similar issues. The recalled drug, Biocor, contains bisoprolol fumarate and is approved for the treatment of hypertension, angina, and stable, moderate-to-severe chronic heart failure.
The National Health Insurance Administration's data reveals that 750,151 tablets of the medication were dispensed through the National Health Insurance program in 2025. Under the Pharmaceutical Affairs Act, pharmaceutical companies that fail to conduct recalls as required by law may face fines ranging from NT$200,000 (US$6,317) to NT$5 million.
Liu assured that there is no concern about a shortage of medication, as more than 10 other drugs with the same active ingredient, dosage form, and strength are licensed in Taiwan. For those worried about their medication, Liu advised consulting their doctors promptly to consider switching to an appropriate alternative.