ACME UNITED CORPORATION Class II Drug Recall D-0376-2026
Summary
The FDA has initiated a Class II drug recall for ACME UNITED CORPORATION's Dynarex 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 (D-0376-2026) for ACME UNITED CORPORATION's Dynarex BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%). The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. The affected product, manufactured for Dynarex Corporation, was distributed nationwide within the United States.
This recall signifies a significant product safety and manufacturing compliance issue. Companies involved in drug manufacturing must ensure adherence to CGMP standards to prevent similar recalls. While the document does not specify a compliance deadline for action by other entities, the ongoing nature of the recall implies immediate attention is required for any affected product in the supply chain. Failure to comply with recall procedures or CGMP can lead to further enforcement actions by the FDA.
What to do next
- Review inventory for recalled Dynarex BZK Antiseptic Towelettes (NDC 67777-245-04).
- Quarantine and segregate any affected product.
- Follow FDA and manufacturer instructions for product return or destruction.
Source document (simplified)
ACME UNITED CORPORATION
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0376-2026 · 20260311 · Ongoing
Product
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04.
Reason for Recall
CGMP Deviations
Distribution
Nationwide within the United States
Source: openFDA Enforcement API
CFR references
Related changes
Source
Classification
Who this affects
Taxonomy
Browse Categories
Get Pharma & Drug Safety alerts
Weekly digest. AI-summarized, no noise.
Free. Unsubscribe anytime.
Get alerts for this source
We'll email you when FDA: Drug Recalls Class II publishes new changes.