Changeflow GovPing Pharma & Drug Safety FDA Class II Recall of Antiseptic Wipes
Urgent Enforcement Removed Final

FDA Class II Recall of Antiseptic Wipes

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 Green Guard Antiseptic Wipes due to CGMP deviations. The product was distributed nationwide in the United States. This recall is ongoing.

What changed

The Food and Drug Administration (FDA) has classified a recall of Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%) as Class II, identified by docket number D-0374-2026. The reason for the recall is cited as Current Good Manufacturing Practice (CGMP) deviations. The product, distributed nationwide, includes specific lot information and NDC number 47682-056-73.

This action signifies a significant compliance issue for the manufacturer and distributor, ACME UNITED CORPORATION. Companies involved in the distribution chain must ensure affected products are identified and removed from circulation. While specific penalties are not detailed, CGMP deviations can lead to regulatory scrutiny and potential future enforcement actions if not adequately addressed. The ongoing nature of the recall suggests active management of the issue by the responsible parties.

What to do next

  1. Identify and remove affected Green Guard Antiseptic Wipes from inventory and patient use.
  2. Review internal CGMP compliance to prevent recurrence.
  3. Consult FDA recall guidelines for specific reporting and remediation steps.

Source document (simplified)

ACME UNITED CORPORATION

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0374-2026 · 20260311 · Ongoing

Product

Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73

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-0374-2026
Docket
D-0374-2026

Who this affects

Applies to
Drug manufacturers Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Recalls CGMP Compliance
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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