FDA Class II Drug Recall: Acme United Corporation

FDA: Drug Recalls Class II

Filed March 11th, 2026

Detected March 23rd, 2026

Summary

The FDA has announced an ongoing Class II drug recall initiated by Acme United Corporation for Med Nap BZK Antiseptic Towelettes. The recall is due to CGMP deviations and affects nationwide distribution within the United States.

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What changed

The U.S. Food and Drug Administration (FDA) has reported an ongoing Class II drug recall initiated voluntarily by Acme United Corporation. The recall concerns Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) due to Current Good Manufacturing Practice (CGMP) deviations. The affected product was distributed nationwide within the United States.

Companies involved in drug manufacturing should be aware of this recall and the reasons cited (CGMP deviations). While this is a voluntary recall, it highlights the importance of adhering to manufacturing standards. Compliance officers should review their internal CGMP practices and ensure robust quality control measures are in place to prevent similar issues. No specific compliance deadline is mentioned for other entities, but the recall itself is ongoing.

What to do next

Review internal CGMP practices for antiseptic towelettes
Ensure robust quality control measures are in place

Source document (simplified)

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