ACME UNITED CORPORATION Class II Drug Recall D-0366-2026
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
- Review CGMP compliance for antiseptic towelette manufacturing.
- Ensure adherence to recall procedures for affected product batches.
- 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
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