FDA-Drug2026-03-11Class IIPROCESSING DEFECT
Dukal BZK Antiseptic Towelette recalled for manufacturing quality deviations
What this means
Dukal BZK Antiseptic Towelettes were manufactured without meeting federal quality standards (CGMP deviations). Affected lots were distributed nationwide. No injuries have been reported.
- 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)
- Stop using the product if you have an affected lot
- Contact Dukal, LLC at the manufacturer address on the package for further instructions
The agency's original wording
Hazard
CGMP Deviations
Intended for
All ages
Illnesses reported
None reported
Sold states
Nationwide within the United States
Affected count
N/A
Manufactured in
1 Waterview Dr Ste 200, N/A, Shelton, CT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0360-2026Want us to check the next one for you?
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