事件過程：
- 民眾如赴美國旅遊，應避免購買及食用問題食品。
- 大腸桿菌廣泛存在於人體或動物體的腸管內，藉由已受感染之人員或動物糞便而污染食品或水源，可分成「非病原性」及「病原性」；非病原性大腸桿菌廣泛存在於人體或動物體的腸管內，然病原性大腸桿菌易引起下痢、腹痛等症狀，藉由已受感染的人員或動物糞便而污染食品或水源。
- 腸道出血性大腸桿菌 (enterohaemorrhagic E. coli, EHEC) 的毒性很強，為一種人畜共通菌，主要存在於牛、羊的腸道與排泄物內。人體多因食入牲畜排泄物污染的食品而感染，通常是食用未澈底加熱之食品而遭受污染。(詳細資料可參考食品藥物管理署防治食品中毒專區，連結https://www.fda.gov.tw/TC/siteContent.aspx?sid=1944)
- 民眾以個人自用自國外攜回或郵寄回國產品，其金額及數量單項價值在1000美元以下，重量在6公斤以內，得免申請食品輸入查驗，惟輸入供販賣或雖為「個人」自用但超過免驗限量者，仍須依食安法第30條辦理申請食品輸入查驗，違者將依食安法第47條處辦。
- 旅客攜帶及自外國郵寄入境產品，另應依財政部關務署「入境旅客攜帶行李物品報驗稅放辦法」及「郵包物品進出口通關辦法」之規定辦理，其中活動物及其產品、活植物及其生鮮產品禁止攜帶。動植物產品另涉農業部動植物防疫檢疫署動植物檢疫規定者，請洽該署(https://www.aphia.gov.tw/)查詢。
對消費者之建議：
- 美國食品藥物管理局(FDA)於114年10月28日發布業者回收Purity Products品牌之膳食補充劑產品(Dietary Supplement for bladder support)，原因係產品存在大腸桿菌污染(Potential contamination with Escherichia coli O7:K1 and 1303)，經查回收產品未有申請食品輸入查驗紀錄。
- 回收產品資訊如下：
Company Announcement Date:October 28, 2025
FDA Publish Date:October 28, 2025
Product Type:Dietary Supplements
Reason for Announcement:Potential contamination with Escherichia coli O7:K1 and 1303
Company Name:Dwater
Brand Name:Purity Products
Product Description:Dietary Supplement for bladder support
Company Announcement
Plainview, NY. October 27, 2025— Purity Products is announcing a recall of one lot of its dietary supplement MyBladder because it has the potential to be contaminated with Escherichia coli O7:K1 and 1303. The presence of these E. coli strains may pose a risk for gastrointestinal or other infections, particularly in vulnerable individuals such as neonates, young children, older adults, and those with weakened immune systems. The recall is being conducted as a precaution to protect all consumers and uphold product safety.
MyBladder was distributed in the U.S. through direct delivery to consumers, through the Walmart and Amazon websites.
The product comes in a white HDPE bottle with a white cap. The bottle size is 150 CC. The net contents in 60 clear capsules containing brown powder. The affected lot is number 03042517.
Our routine testing has detected two strains of E. coli - O7:K1 (IAI39/ExPEC) and E. coli 1303 – in lot number 03042517 of this product. These strains are not permitted in dietary supplements under current regulatory standards. Subsequent investigation indicates the problem was caused by a temporary change in suppliers.
- 經查回收產品未有申請食品輸入查驗紀錄(迄114年10月28日止)，故判定為綠燈。
- 原警訊連結如下：
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/purity-products-announces-recall-dietary-supplement-my-bladder-because-possible-health-risk對食品業者之建議：
- 案內回收產品目前未有申請輸入查驗紀錄，業者應避免輸入疑慮產品。
- 若有輸入或使用類似或疑似回收警訊產品或相關產品，應立即向外國原廠、出口廠商或國內供應商查證，並依自主管理原則，主動暫停該等疑慮產品之販售或使用。
- 若獲原廠或供應商通知已輸入產品為需回收產品，應立即主動下架回收，通知消費者退換貨，並通知公司所在地衛生單位與本署。
- 建議業者得於採購前要求原廠或上游供應商提具產品檢驗報告，或自主管理評估進行相關衛生項目檢驗，確保製販售或輸入產品之衛生安全並符合我國規定。