Recalls / Class II

Class IID-0589-2025

Product

BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu, China, NDC: 71310-111-01

Affected lot / code info

Lot Numbers: 220583459, 230553459, 232743459, 110523, 031524, 052224, 247793459

Why it was recalled

Lack of Assurance of Sterility.

Recalling firm

Firm

Taizhou Kangping Medical Science And Technology Co., Ltd.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

Hailing Industrial Park, 27 Tai'An Road, Taizhou, N/A N/A, China

Distribution

Quantity

3.85 million Cartons

Distribution pattern

NY

Timeline

Recall initiated

2025-07-22

FDA classified

2025-08-18

Posted by FDA

2025-08-27

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0589-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.