ACME UNITED CORPORATION Class II Drug Recall D-0358-2026
Summary
The FDA has initiated a Class II drug recall (D-0358-2026) for ACME UNITED CORPORATION's First Aid Only BZK Antiseptic Towelettes due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects a nationwide distribution within the United States.
What changed
The FDA has issued a Class II drug recall (D-0358-2026) for ACME UNITED CORPORATION's BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%, 100 Wipes, NDC 0924-7116-04). The recall is due to Current Good Manufacturing Practice (CGMP) deviations and affects nationwide distribution within the United States. The recall is ongoing as of March 11, 2026.
Drug manufacturers and distributors involved in the supply chain of this product must immediately identify and segregate affected inventory. Compliance officers should review their CGMP adherence and distribution records to ensure no further issues arise and to cooperate with any FDA requests related to this recall. Failure to comply with recall procedures can result in further enforcement actions.
What to do next
- Identify and segregate affected product inventory
- Review CGMP adherence and distribution records
- Cooperate with FDA requests related to the recall
Source document (simplified)
ACME UNITED CORPORATION
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0358-2026 · 20260311 · Ongoing
Product
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04
Reason for Recall
CGMP Deviations
Distribution
Nationwide within the United States
Source: openFDA Enforcement API
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