ACME UNITED CORPORATION Class II Drug Recall D-0369-2026
Summary
The FDA has initiated a Class II drug recall (D-0369-2026) for Dynarex Obstetrical Towelettes Cleanser manufactured by ACME UNITED CORPORATION due to CGMP deviations. The recall affects product distributed nationwide within the United States.
What changed
The FDA has issued a Class II drug recall (D-0369-2026) for Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%) manufactured for Dynarex Corporation. The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. The product was distributed nationwide across the United States.
Drug manufacturers and distributors must immediately identify and quarantine affected product lots. Compliance officers should review their CGMP adherence and distribution records to ensure no further affected product remains in circulation. While specific penalties are not detailed, failure to comply with recall procedures can result in significant regulatory action and reputational damage.
What to do next
- Identify and quarantine affected product lots
- Review CGMP adherence and distribution records
Source document (simplified)
ACME UNITED CORPORATION
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0369-2026 · 20260311 · Ongoing
Product
Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 677...
Reason for Recall
CGMP Deviations
Distribution
Nationwide within the United States
Source: openFDA Enforcement API
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