CLASS II ONGOING Drug recall · Reported 11 Mar 2026 · FDA Enforcement Report
Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) recalled
Acme United is recalling Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), distributed nationwide in the US. The recall was initiated on 20 Jan 2026 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-0360-2026
- FDA event ID
- 98291
- Recalling firm
- Acme United, Shelton, CT
- Brand
- Bzk Towelette
- Manufacturer
- Dukal LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Jan 2026
- FDA classified
- 2 Mar 2026
- Reported
- 11 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 20 Jan 2026 | Recall initiated by company | |
| 2 Mar 2026 | Classified by FDA | +41 days |
| 11 Mar 2026 | 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
CGMP Deviations
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
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.
Where was it sold?
Nationwide within the United States
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.
Other products in this recall event
20 other products · FDA event 98291This product is part of a recall event; the main page for the event is Med Nap BZK Antiseptic Towelettes recalled by Acme United.
More recalls from Acme United
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Children's Healthcare of Atlanta recalled by Acme United | Acme United | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) recalled | Acme United | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | WP WipesPlus Hand Sanitizing Wipes recalled by Acme United | Acme United | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Cleansing Towelette (Benzalkonium Chloride 0.13%) recalledMed Nap Cleansing Towelette | Acme United | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%) recalledGreen Guard Antiseptic Wipes | Acme United | Manufacturing (CGMP) Deviations | Nationwide |
Other Benzalkonium Chloride recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Trifluent Pharma Tridergel Wound Care Gel recalled by Blaine LabsTridergel | Blaine Labs | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Revitaderm Wound Care, First Aid Antiseptic Gel recalled by Blaine LabsRevitaderm Wound Care | Blaine Labs | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Cleansing Towelette (Benzalkonium Chloride 0.13%) recalledMed Nap Cleansing Towelette | Acme United | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%) recalledGreen Guard Antiseptic Wipes | Acme United | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Medi-First Antiseptic Wipes recalled by Acme UnitedMedi-first Antiseptic Wipes | Acme United | Manufacturing (CGMP) Deviations | Nationwide |