FDA Recall Notice: BZK Antiseptic Towelettes

Taizhou Kangping Medical Science and Technology Co., Ltd. has voluntarily initiated a recall of its BZK Antiseptic Towelettes (benzalkonium chloride 0.13%), packaged as 100 sterile towelettes per carton and labeled for professional use. The affected products were manufactured in Taizhou, JiangSu, China, and distributed in New York. According to the US Food & Drug Administration (FDA) Enforcement Report, the recall covers 3.85 million cartons across several lot numbers, including 220583459, 230553459, 232743459, 110523, 031524, 052224, and 247793459. No press release has been issued, though consignees were formally notified by letter.

The recall was classified as a Class II recall, meaning use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences, with the probability of serious harm considered remote. The action was prompted by a lack of assurance of sterility, which poses a concern given the product’s intended external antiseptic use. The recall remains ongoing as of the latest FDA update.

Benzalkonium chloride (BZK) antiseptic towelettes are widely used in clinical and professional health care settings for skin antisepsis prior to procedures, wound cleaning, and general disinfection of minor cuts, scrapes, and burns.