CLASS II ONGOING Drug recall · Reported 27 Aug 2025 · FDA Enforcement Report
BZK Antiseptic Towelette, Sterile, For External Use Only recalled
Taizhou Kangping Medical Science And Technology is recalling BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, distributed in New York. The recall was initiated on 22 Jul 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0589-2025
- FDA event ID
- 97344
- Recalling firm
- Taizhou Kangping Medical Science And Technology, Taizhou, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Jul 2025
- FDA classified
- 18 Aug 2025
- Reported
- 27 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 22 Jul 2025 | Recall initiated by company | |
| 18 Aug 2025 | Classified by FDA | +27 days |
| 27 Aug 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
NY
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility.
Which lots are affected?
Lot Numbers: 220583459, 230553459, 232743459, 110523, 031524, 052224, 247793459
Where was it sold?
NY
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.