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Drug FDA Class II Ongoing Contamination / non-sterility

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

Taizhou Kangping Medical Science And Technology Co., Ltd. Published Aug 27, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 50/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Taizhou Kangping Medical Science And Technology Co., Ltd. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility.

Hazards

Lack of Sterility Assurance · primary

Affected products (1)

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

3.85 million Cartons

Lot codes: Numbers
Code info: Lot Numbers: 220583459, 230553459, 232743459, 110523, 031524, 052224, 247793459

Affected areas

New York

Timeline

  1. Initiated
    Jul 22, 2025
  2. Published
    Aug 27, 2025
Recall number
D-0589-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.