BZK TOWELETTE
Recalling Firm / Manufacturer: ACME UNITED CORPORATION
(Shelton, CT, United States)
FDA Recall Number: D-0360-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
BZK TOWELETTE
Generic Name
BENZALKONIUM CHLORIDE
Active Substance(s)
Benzalkonium Chloride
Administration Route
Topical
National Drug Code (NDC)
65517-0004
Total Quantity Recalled
N/A
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
CGMP Deviations
Full Product Description
Packaging specifications and labeling details
Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY 11779, Made in USA, NDC 65517-0004-1
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
March 11, 2026
Firm Initiation Date
January 20, 2026
FDA Classification Date
Mar 02, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: MN31621, Exp. Date Oct 2026; MN14522, MN15522, Exp. Date Apr 2027; MN28122, MN31522, Exp. Date Sept 2027; MN04223, MN06023, Exp. Date Feb 2028; MN17223, Exp. Date May 2028; MN25123, Exp Date Aug 2028; MN33123, MN33523, Exp. Date Nov 2028.
Distribution Information
Geographic scope of affected shipments
Nationwide within the United States
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0360-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508606UTCC