Acme United Corporation Recalls Med Nap Benzalkonium Chloride Antiseptic Towelettes Due to CGMP Deviations
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Acme United Corporation has voluntarily recalled several lots of Med Nap BZK Antiseptic Towelettes due to deviations from Current Good Manufacturing Practice (CGMP) requirements.
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 Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%). The recall was triggered by deviations from Current Good Manufacturing Practice (CGMP) requirements. The FDA has classified this as a Class II recall, which was officially reported on March 11, 2026.
Which Products Are Affected
The recall affects Med Nap BZK Antiseptic Towelettes packaged in boxes of 100. The products are identified by NDC 0924-0246-01 and UPC 0092265940061. The recall number is D-0366-2026.
The following lot numbers and expiration dates are included in the recall:
- Lot MN09322 (Exp: Mar 2027)
- Lot MN15222 (Exp: May 2027)
- Lot MN21622 (Exp: Jul 2027)
- Lot MN31822 (Exp: Oct 2027)
- Lots MN06223, MN06323 (Exp: Feb 2028)
- Lot MN12523 (Exp: Apr 2028)
- Lot MN16123 (Exp: May 2028)
- Lots MN20523, MN20623, MN20723 (Exp: Jun 2028)
- Lot MN23223 (Exp: Jul 2028)
- Lot MN31123 (Exp: Oct 2028)
- Lots MN300524, MN300624, MN302624, MN302724, MN303324 (Exp: Dec 2028)
These products were distributed nationwide across the United States.
What You Should Do
Consumers who have purchased the affected antiseptic towelettes should stop using them immediately. While the source data does not specify a direct refund process, consumers typically contact the manufacturer, Acme United Corporation, located at 1 Waterview Dr, Shelton, CT, for further instructions regarding the return or disposal of the product.
Why This Matters
Adherence to Current Good Manufacturing Practice (CGMP) is essential to ensure the safety, identity, strength, quality, and purity of drug products. Deviations from these standards can compromise the integrity of the antiseptic wipes, potentially impacting their effectiveness or safety.
Source
This information is based on official recall data from the U.S. Food and Drug Administration (FDA).
Original source: FDA Official Notice ↗
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