Bzk Towelette Swab
FDA Recall NDC 65517-0004
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Bzk Towelette (NDC 65517-0004). A significant event, classified as Class II, was initiated on Jan 20, 2026 by Dukal Llc. The reported reason for this action was: "CGMP Deviations"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations
Jan 20, 2026
Mar 11, 2026
N/A
Recall Profile & Regulatory Data
Event ID
98291
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ACME UNITED CORPORATION
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
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
Batch or Lot Expiration Information
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.
Affected Packages Involved in this Recall
65517-0004-1Product
65517-0004-2Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
