Acme United Corporation Recalls Dukal BZK Antiseptic Towelettes Due to CGMP Deviations

What Happened

Acme United Corporation has initiated a voluntary recall of Dukal BZK Antiseptic Towelettes. The recall, classified as Class II by the FDA, was prompted by Current Good Manufacturing Practice (CGMP) deviations. The recall was officially initiated on January 20, 2026, following notification sent to distributors and customers via letter.

Which Products Are Affected

The recall affects Dukal BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) packaged in cases of 1,000 packs. The product is identified by NDC 65517-0004-1 and was manufactured for Dukal, LLC.

The following lot numbers and expiration dates are included in this recall:

• Lot MN31621: Expiration October 2026
• Lots MN14522, MN15522: Expiration April 2027
• Lots MN28122, MN31522: Expiration September 2027
• Lots MN04223, MN06023: Expiration February 2028
• Lot MN17223: Expiration May 2028
• Lot MN25123: Expiration August 2028
• Lots MN33123, MN33523: Expiration November 2028

These products were distributed nationwide within the United States.

What You Should Do

Consumers, retailers, and healthcare providers should immediately check their inventory for the affected lot numbers listed above. If you possess any of the recalled towelettes, you should stop using them. Acme United Corporation initiated the notification process via letter; affected parties should follow the instructions provided in that communication for the return or disposal of the product. For further information, the recalling firm is located in Shelton, CT.

Why This Matters

This recall is significant because CGMP deviations indicate that the manufacturing process did not meet the required regulatory standards to ensure the product’s quality, strength, and purity. A Class II classification suggests that use of the product may cause temporary or medically reversible adverse health consequences.

Source

Information provided by the FDA under recall number D-0360-2026.