ACME UNITED CORPORATION Class II Recall D-0362-2026 for BZK Antiseptic Towelettes
Summary
The FDA has issued a Class II recall (D-0362-2026) for ACME UNITED CORPORATION's BZK Antiseptic Towelettes due to CGMP deviations. The recall affects product distributed nationwide within the United States.
What changed
The Food and Drug Administration (FDA) has initiated a Class II recall, designated D-0362-2026, for ACME UNITED CORPORATION's BZK Antiseptic Towelettes. The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. The affected product is described as BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) in 5"x7" size, packaged in bulk 1,000-count units, and distributed nationwide.
This recall signifies a critical compliance issue for ACME UNITED CORPORATION and potentially other entities involved in the supply chain. Companies involved in drug manufacturing must ensure strict adherence to CGMP regulations to prevent such deviations. While the document does not specify a compliance deadline for the recall itself, the ongoing nature and the reason for recall (CGMP deviations) indicate a need for immediate corrective actions by the manufacturer and potentially distributors to manage the affected product and address the underlying manufacturing deficiencies.
What to do next
- Review manufacturing processes for CGMP compliance
- Implement corrective actions to address identified deviations
- Ensure proper handling and reporting of recalled products
Source document (simplified)
ACME UNITED CORPORATION
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0362-2026 · 20260311 · Ongoing
Product
1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00....
Reason for Recall
CGMP Deviations
Distribution
Nationwide within the United States
Source: openFDA Enforcement API
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