FDA Recall D-0360-2026

ACME UNITED CORPORATION · Shelton, CT

Class II Ongoing 114 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: 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.

Quantity: N/A

Reason for recall

CGMP Deviations

Recall record

Recall number: D-0360-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2026-01-20
Classified by FDA Center: 2026-03-02
FDA published: 2026-03-11
Recalling firm: ACME UNITED CORPORATION
Firm location: Shelton, CT

Drug identification

Brand name(s): BZK TOWELETTE
Generic name(s): BENZALKONIUM CHLORIDE
Manufacturer(s): Dukal LLC
NDC(s): 65517-0004
Route(s): TOPICAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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