Changeflow GovPing Pharma & Drug Safety ACME UNITED CORPORATION Class II Drug Recall D-...
Urgent Enforcement Removed Final

ACME UNITED CORPORATION Class II Drug Recall D-0375-2026

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

The FDA has initiated a Class II drug recall for ACME UNITED CORPORATION's Dynarex BZK Antiseptic Towelettes due to CGMP deviations. The recall affects product distributed nationwide in the United States.

What changed

The Food and Drug Administration (FDA) has issued a Class II drug recall (D-0375-2026) for Dynarex BZK Antiseptic Towelettes manufactured for Dynarex Corporation. The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. The affected product, NDC 67777-245-01, was distributed nationwide within the United States.

This recall signifies a significant compliance issue for the manufacturer, potentially impacting product efficacy or safety. Companies involved in drug manufacturing must ensure strict adherence to CGMP regulations to prevent similar recalls. While specific compliance actions for Dynarex Corporation are ongoing, the nature of a Class II recall suggests a potential for adverse events, necessitating prompt corrective actions by the manufacturer and awareness among distributors and healthcare providers regarding the affected product.

What to do next

  1. Review CGMP compliance for antiseptic towelettes
  2. Verify product distribution records for affected lots
  3. Implement corrective actions to address CGMP deviations

Source document (simplified)

ACME UNITED CORPORATION

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0375-2026 · 20260311 · Ongoing

Product

Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01

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-0375-2026

Who this affects

Applies to
Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Manufacturing Product Recall
Threshold
Class II drug recall
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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