Recalls / Class II
Class IID-0360-2026
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
- Brand name
- Bzk Towelette
- Generic name
- Benzalkonium Chloride
- Active ingredient
- Benzalkonium Chloride
- Route
- Topical
- NDC
- 65517-0004
- FDA application
- M003
- Affected lot / code info
- 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.
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- ACME UNITED CORPORATION
- Manufacturer
- Dukal LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Waterview Dr Ste 200, N/A, Shelton, Connecticut 06484-4368
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2026-01-20
- FDA classified
- 2026-03-02
- Posted by FDA
- 2026-03-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0360-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.