Acme United Corporation Recalls First Aid Only Hand Sanitizing Wipes Due to Manufacturing Deviations

Source: FDA · United States

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Acme United Corporation has issued a voluntary recall for specific lots of First Aid Only Hand Sanitizing Wipes due to Current Good Manufacturing Practice (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.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, HandSanitizer) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Acme United Corporation has initiated a voluntary Class II recall of its First Aid Only Hand Sanitizing Wipes. The recall was triggered by Current Good Manufacturing Practice (CGMP) deviations identified by the manufacturer. The recall process was officially initiated on January 20, 2026.

Which Products Are Affected

The recall involves First Aid Only Hand Sanitizing Wipes containing Benzalkonium Chloride 0.13%. The products are packaged 1,000 per case and were distributed nationwide across the United States.

Specific identification details include:

  • Product Name: First Aid Only Hand Sanitizing Wipe
  • NDC Number: 0924-0301-00
  • Lot Numbers and Expiration Dates:
    • Lot #: MN24922, Exp. Date Aug 2027
    • Lot #: MN31122, Exp. Date Oct 2027
  • Recall Number: D-0373-2026

What You Should Do

Consumers and businesses in possession of the affected lots should stop using the product immediately. The firm initiated the notification process via letter. For information regarding returns or disposal of the affected wipes, consumers may contact Acme United Corporation at their headquarters located at 1 Waterview Dr Ste 200, Shelton, CT 06484.

Why This Matters

CGMP deviations indicate that the manufacturing process did not meet the required standards to ensure the product's quality, safety, and efficacy. Such deviations can potentially lead to products that are contaminated or do not contain the specified levels of active ingredients.

Source

Information provided by the FDA.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Acme United Corporation has issued a voluntary recall for specific lots of First Aid Only Hand Sanitizing Wipes due to Current Good Manufacturing Practice (CGMP) deviations.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.