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ACME UNITED CORPORATION Class II Drug Recall D-0376-2026

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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 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 (D-0376-2026) for ACME UNITED CORPORATION's Dynarex BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%). The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. The affected product, manufactured for Dynarex Corporation, was distributed nationwide within the United States.

This recall signifies a significant product safety and manufacturing compliance issue. Companies involved in drug manufacturing must ensure adherence to CGMP standards to prevent similar recalls. While the document does not specify a compliance deadline for action by other entities, the ongoing nature of the recall implies immediate attention is required for any affected product in the supply chain. Failure to comply with recall procedures or CGMP can lead to further enforcement actions by the FDA.

What to do next

  1. Review inventory for recalled Dynarex BZK Antiseptic Towelettes (NDC 67777-245-04).
  2. Quarantine and segregate any affected product.
  3. Follow FDA and manufacturer instructions for product return or destruction.

Source document (simplified)

ACME UNITED CORPORATION

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0376-2026 · 20260311 · Ongoing

Product

Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04.

Reason for Recall

CGMP Deviations

Distribution

Nationwide within the United States

Source: openFDA Enforcement API

CFR references

21 CFR 211

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-0376-2026

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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