Taipei: Taiwan’s Food and Drug Administration (FDA) has initiated a recall of two batches of a hypothyroidism medication after stability tests revealed that the levels of its active ingredient, levothyroxine sodium, were below standard. This shortfall has the potential to diminish the drug’s effectiveness, an FDA official disclosed.
According to Focus Taiwan, the affected batches, D2402370 and D2402371, belong to Thyrocure 50 mcg and consist of over 1.12 million tablets manufactured by Biofrontier Inc., Asia. The medicine is primarily used to treat hypothyroidism, a condition characterized by an underactive thyroid gland.
FDA official Yang Po-wen informed CNA that Biofrontier Inc. voluntarily notified the FDA on September 30 after three-month stability tests indicated a drop in the active ingredient content below the required specification limit. This reduction could compromise the drug’s therapeutic efficacy.
Yang stated that the FDA has mandated the completion of the recall by November 3. Out of the affected batches, 1,123,000 tablets have already been distributed, while 1,175,760 tablets remain in stock, which could last for approximately 49 months of domestic supply. Biofrontier Inc. also plans to import an additional 500,000 tablets, equating to about 21 months of supply, during the first quarter of 2026.
