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ACME UNITED CORPORATION Class II Recall D-0362-2026 for BZK Antiseptic Towelettes

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Filed March 11th, 2026
Detected March 28th, 2026
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Summary

The FDA has issued a Class II recall (D-0362-2026) for ACME UNITED CORPORATION's BZK Antiseptic Towelettes due to CGMP deviations. The recall affects product distributed nationwide within the United States.

What changed

The Food and Drug Administration (FDA) has initiated a Class II recall, designated D-0362-2026, for ACME UNITED CORPORATION's BZK Antiseptic Towelettes. The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. The affected product is described as BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) in 5"x7" size, packaged in bulk 1,000-count units, and distributed nationwide.

This recall signifies a critical compliance issue for ACME UNITED CORPORATION and potentially other entities involved in the supply chain. Companies involved in drug manufacturing must ensure strict adherence to CGMP regulations to prevent such deviations. While the document does not specify a compliance deadline for the recall itself, the ongoing nature and the reason for recall (CGMP deviations) indicate a need for immediate corrective actions by the manufacturer and potentially distributors to manage the affected product and address the underlying manufacturing deficiencies.

What to do next

  1. Review manufacturing processes for CGMP compliance
  2. Implement corrective actions to address identified deviations
  3. Ensure proper handling and reporting of recalled products

Source document (simplified)

ACME UNITED CORPORATION

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0362-2026 · 20260311 · Ongoing

Product

1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00....

Reason for Recall

CGMP Deviations

Distribution

Nationwide within the United States

Source: openFDA Enforcement API

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
March 11th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
D-0362-2026

Who this affects

Applies to
Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Manufacturing Product Recalls
Geographic scope
United States US

Taxonomy

Primary area
Food Safety
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Product Recalls Manufacturing Compliance

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