FDA Recall D-0589-2025

Taizhou Kangping Medical Science And Technology Co., Ltd. · Taizhou, N/A

Class II Ongoing 296 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

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

Quantity: 3.85 million Cartons

Reason for recall

Lack of Assurance of Sterility.

Recall record

Recall number: D-0589-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: NY
Recall initiated: 2025-07-22
Classified by FDA Center: 2025-08-18
FDA published: 2025-08-27
Recalling firm: Taizhou Kangping Medical Science And Technology Co., Ltd.
Firm location: Taizhou, N/A, China

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls