Taiwan Recalls 586,000 Heart Failure Pills Due to Impurity Concerns

Taiwan's regulatory body has ordered a recall of a significant number of heart failure medication tablets due to concerns over impurity levels. The Food and Drug Administration (FDA) announced that 586,000 tablets of 'Biocor Film Coated Tablets 5 mg' must be recalled by the end of the month.

The medication, manufactured by Ying Yuan Biotechnology Pharmaceutical Co., Ltd., is prescribed for conditions including hypertension, angina, and stable chronic moderate to severe heart failure. The recall was initiated after a stability test at 31 months revealed that impurity content had reached the upper limit of the specified standards. This elevation raises concerns that the drug's quality and therapeutic stability could be compromised, potentially impacting its effectiveness.

According to the FDA, the active ingredient in the affected tablets is bisoprolol fumarate. Data from the National Health Insurance Administration indicates that the drug was used in 750,151 doses in 2025. The FDA has instructed the manufacturer to complete the recall process and submit a report on its outcomes, along with subsequent corrective actions.

While the recall is underway, the FDA assures the public that there is no risk of drug shortages. Over 10 alternative medications with the same active ingredient, dosage, and form are available in Taiwan. Patients with concerns about their medication are advised to consult their physician promptly to discuss alternative treatment options.

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The impurity content reached the upper limit of the inspection specifications, which may affect the drug's quality and efficacy stability.