Acme United Corporation Recalls Dynarex BZK Antiseptic Towelettes Due to Manufacturing Deviations
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Acme United Corporation has issued a voluntary recall for specific lots of Dynarex BZK Antiseptic Towelettes distributed nationwide due to CGMP deviations.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 2, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
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What Happened
Acme United Corporation has initiated a voluntary recall of Dynarex BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%). The recall was triggered by deviations from Current Good Manufacturing Practices (CGMP). The U.S. Food and Drug Administration (FDA) has designated this as a Class II recall, which was officially classified on March 2, 2026.
Which Products Are Affected
The recall involves Dynarex brand BZK Antiseptic Towelettes packaged in 5x7 inch packets, typically sold in cases of 1,000. The following specific identifiers are associated with the recalled products:
- Brand Name: Dynarex
- Product Description: BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%)
- Lot Numbers: 53518 and 53519
- Expiration Date: June 2027
- NDC Number: 67777-245-04 (and related package NDCs including 67777-245-01, 67777-245-11, 67777-245-02, 67777-245-14, 67777-245-15, 67777-245-05, 67777-245-06, 67777-245-16, 67777-245-08, 67777-245-18, 67777-245-07, and 67777-245-17)
- UPCs: 0616784133225, 0840117329331, 0840117329355, 0616784133324, 0616784130323, 0840117329379, 0616784133133
The products were distributed nationwide throughout the United States.
What You Should Do
Consumers, healthcare facilities, and retailers should immediately check their inventory for the affected lot numbers (53518 and 53519). If these products are identified, they should be set aside and not used. The recalling firm, Acme United Corporation, initiated notification to customers via letter. For information regarding returns or replacement, parties should contact Acme United Corporation at their Shelton, CT headquarters.
Why This Matters
This recall is significant because Current Good Manufacturing Practice (CGMP) deviations indicate that the product may not have been manufactured under standards that ensure quality and safety. A Class II classification suggests that use of the product may cause temporary or medically reversible adverse health consequences.
Source
Information provided by the U.S. Food and Drug Administration (FDA). Recall Number: D-0376-2026.
Original source: FDA Official Notice ↗
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