Changeflow GovPing Pharma & Drug Safety ACME UNITED CORPORATION Class II Recall: BZK An...
Urgent Enforcement Added Final

ACME UNITED CORPORATION Class II Recall: BZK Antiseptic Towelettes

Favicon for changeflow.com FDA: Drug Recalls Class II
Filed March 11th, 2026
Detected March 28th, 2026
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Summary

The FDA has initiated a Class II recall 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 issued a Class II recall for ACME UNITED CORPORATION's BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%, NDC 0924-0246-02). This action is due to Current Good Manufacturing Practice (CGMP) deviations identified by the agency. The affected product was distributed nationwide across the United States.

Companies involved in the manufacturing or distribution of these antiseptic towelettes must immediately review their CGMP compliance and recall procedures. While specific compliance deadlines are not detailed, the nature of a Class II recall necessitates prompt action to ensure product safety and adherence to regulatory standards. Failure to comply with recall procedures can result in further enforcement actions by the FDA.

What to do next

  1. Review CGMP compliance for antiseptic towelette manufacturing.
  2. Implement recall procedures for affected product batches.
  3. Ensure adherence to FDA recall guidelines.

Source document (simplified)

ACME UNITED CORPORATION

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0367-2026 · 20260311 · Ongoing

Product

BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0246-02.

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-0367-2026

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
Pharmaceuticals
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Product Safety Manufacturing Compliance

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