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ACME UNITED CORPORATION Class II Drug Recall D-0366-2026

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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 (D-0366-2026) for ACME UNITED CORPORATION's Med Nap BZK Antiseptic Towelettes due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects product distributed nationwide within the United States.

What changed

The FDA has issued a Class II drug recall for ACME UNITED CORPORATION's Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), identified by recall number D-0366-2026. The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified by the agency. The affected product, NDC 0924-0246-01, was manufactured by Acme United Corporation and distributed nationwide in the United States.

This recall signifies a significant compliance issue for Acme United Corporation, requiring immediate action to address the CGMP deviations. Companies involved in drug manufacturing must ensure their processes adhere to regulatory standards to prevent similar recalls. While the document does not specify a compliance deadline, the ongoing nature of the recall implies that the company must actively manage the removal of affected products from the market and implement corrective actions to prevent recurrence. Failure to comply with recall procedures can lead to further enforcement actions by the FDA.

What to do next

  1. Review CGMP compliance for antiseptic towelette manufacturing.
  2. Ensure adherence to recall procedures for affected product batches.
  3. Implement corrective actions to address identified CGMP deviations.

Source document (simplified)

ACME UNITED CORPORATION

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0366-2026 · 20260311 · Ongoing

Product

Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01.

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-0366-2026

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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