ACME UNITED CORPORATION Class II Recall D-0370-2026 for Towelettes
Summary
The FDA has issued a Class II recall (D-0370-2026) for ACME UNITED CORPORATION's Cleansing Towelettes due to CGMP deviations. The recall is ongoing and affects nationwide distribution within the United States.
What changed
The FDA has initiated a Class II recall, designated D-0370-2026, for ACME UNITED CORPORATION's Cleansing Towelettes (Benzalkonium Chloride 0.13%) due to deviations from Current Good Manufacturing Practices (CGMP). The product, identified by NDC 0924-0243-00, was distributed nationwide.
Drug manufacturers and distributors involved in the supply chain of this product must immediately review their inventory and recall procedures. While specific compliance deadlines are not detailed in this notice, failure to comply with recall procedures can result in further enforcement actions by the FDA. Companies should ensure their CGMP compliance is up to standard to prevent similar issues.
What to do next
- Review inventory for affected Cleansing Towelettes.
- Implement recall procedures as per FDA guidelines.
- Verify CGMP compliance in manufacturing processes.
Source document (simplified)
ACME UNITED CORPORATION
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0370-2026 · 20260311 · Ongoing
Product
Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00.
Reason for Recall
CGMP Deviations
Distribution
Nationwide within the United States
Source: openFDA Enforcement API
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