Moderate riskFDA DrugClass II

Dukal BZK Antiseptic Towelette recalled for manufacturing quality deviations

Dukal BZK Antiseptic Towelettes were manufactured without meeting federal quality standards (CGMP deviations). Affected lots were distributed nationwide. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if you have Dukal BZK Antiseptic Towelettes with the affected lot numbers (MN31621, MN14522, MN15522, MN28122, MN31522, MN04223, MN06023, MN17223, MN25123, MN33123, or MN33523)
  2. Stop using the product if you have an affected lot
  3. Contact Dukal, LLC at the manufacturer address on the package for further instructions

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 21 products — see all of them.

Details

Units affected
N/A
Illnesses reported
None reported
Manufactured in
1 Waterview Dr Ste 200, N/A, Shelton, CT, United States
Classification
Class II
Recall number
D-0360-2026

In the FDA's words

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 CGMP Deviations 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: Nationwide within the United States Affected quantity: N/A
Hazard
CGMP Deviations

21 products in this recall

First Aid Only and Med-Nap BZK wipes recalled for manufacturing deviations

Acme United Corporation is recalling 21 antiseptic and hand sanitizing towelette and wipe products nationwide for manufacturing (CGMP) deviations, a Class II classification. The products are sold under names including First Aid Only, Med-Nap, Dukal, Dynarex, Piedmont Sanitizing, Max Packaging, Savannah, Medi-First, Wipes Plus, WP WipesPlus, Green Guard, and Children's Healthcare of Atlanta, among others. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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