Heart failure drug "Xinken" contains impurities exceeding the standard, and nearly 4.7 million tablets in 8 batches were recalled

The quality of "Xinken film-coated tablets" used to treat heart failure was found to be abnormal, and the Food and Drug Administration initiated a preventive recall. (Taken from the official website of the Food and Drug Administration)

[Reporter Luo Bi/Reporting from Taipei] "Xinken film-coated tablets" used to treat heart failure were found to have abnormal quality, and a preventive recall was initiated. The Food and Drug Administration's Drug Group, Jian Ren Jizheng and Yang Bowen, said that during the stability test, it was found that the impurity content of a batch of products exceeded the standard, which may affect the quality and efficacy stability of the drug. Therefore, the expanded recall of 1.25 mg and 2.5 mg, a total of 8 batches, 4.699 million tablets, must be completed before November 6.

The Food and Drug Administration announced the recall information on October 27. The drug license holder is Yingshuo Biotech Pharmaceutical Co., Ltd. Four batches of each of the two specifications were recalled this time, and the sold quantities were 2.325 million tablets and 2.374 million tablets respectively. In addition, according to the National Health Insurance Administration data in 2025, the annual declaration volume of the two drugs is approximately 2.08 million tablets and 2.94 million tablets respectively, totaling approximately 5.02 million tablets.

Yang Bowen said that the manufacturer voluntarily reported that during the stability test of the drug in the 24th month, it was found that the impurity content exceeded the upper limit of the inspection specification, and it was initially suspected to be related to the degradation of the drug ingredients. This drug has a validity period of 2 years. Although a batch of products failed to pass the inspection when the validity period expired, the manufacturer still initiated a preventive recall of the relevant batch numbers out of caution.

The "Xinken film-coated tablets 1.25 mg" recalled this time, the license number is Department of Health Drug Manufacturing No. 049851, and the batch numbers include BEB061, BEE061, BEF051 and BEG 051; The license number of "Xinken Film-Coated Tablets 2.5 mg" is Department of Health Drug No. 049915, and the batch numbers are BEB071, BED051, BEE071 and BEG061.

Yang Bowen pointed out that the main ingredient of both drugs is bisoprolol hemifumarate, and the approved indication is stable chronic moderate to severe heart failure. Currently, there are other domestically available drugs with the same ingredients and dosage forms that can be substituted, so there should be no fear of drug shortage.

The Food and Drug Administration has required manufacturers to complete the recall and submit investigation reports and preventive and corrective measures before November 6. If the recall is not carried out in accordance with the regulations, a fine of 200,000 yuan to 5 million yuan will be imposed in accordance with Article 91 of the Pharmaceutical Affairs Law. If the patient has relevant medicines, he should check the batch number first, do not stop taking the medicine on his own, and consult a doctor or pharmacist about changing medicines.