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

ACME UNITED CORPORATION Class II Drug Recall

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 issued a Class II recall for ACME UNITED CORPORATION's Hand Sanitizing Wipes due to CGMP deviations. The recall, identified as D-0373-2026, is ongoing and affects product distributed nationwide in the United States.

What changed

The Food and Drug Administration (FDA) has initiated a Class II recall for ACME UNITED CORPORATION's Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%). The recall, designated D-0373-2026, is due to Current Good Manufacturing Practice (CGMP) deviations. The product, identified by NDC 0924-0301-00 and packaged 1000 per case, was distributed nationwide within the United States.

This recall signifies a significant compliance issue for ACME UNITED CORPORATION, requiring immediate attention to product disposition and corrective actions. Companies in the pharmaceutical and consumer health sectors should review their CGMP compliance, particularly concerning hand sanitizing products, to prevent similar deviations. While no specific compliance deadline is stated, the ongoing nature of the recall implies that corrective actions and product recovery are actively underway.

What to do next

  1. Review CGMP compliance for hand sanitizing products
  2. Assess product disposition and recovery for affected batches

Source document (simplified)

ACME UNITED CORPORATION

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0373-2026 · 20260311 · Ongoing

Product

Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00

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-0373-2026

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

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