Acme United Corporation Recalls Children's Healthcare of Atlanta Hand Sanitizing Wipes

Source: FDA · United States

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Acme United Corporation has issued a voluntary recall for specific lots of Children's Healthcare of Atlanta Instant Hand Sanitizing Wipes 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.

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.

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What Happened

Acme United Corporation, based in Shelton, CT, has initiated a voluntary recall of Children's Healthcare of Atlanta Instant Hand Sanitizing Wipes. The recall was triggered by deviations from Current Good Manufacturing Practice (CGMP) regulations. 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 the following product distributed nationwide within the United States:

  • Product Name: Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe (Benzalkonium Chloride 0.13%)
  • Packaging: 1,000 wipes per case
  • NDC Number: 0924-7130-00
  • Manufacturer Information: Made in USA for Food Service Resources, Flowery Branch, GA
  • Affected Lot Numbers and Expiration Dates:
    • Lot #: MN12122, Exp. Date Apr 2027
    • Lot #: MN27523, Exp. Date Aug 2028
    • Lot #: MN30922, Exp. Date Oct 2027

What You Should Do

Consumers, healthcare providers, and distributors who have the affected lots of hand sanitizing wipes should immediately stop using the product. For further information regarding returns or disposal instructions, parties may contact Acme United Corporation at their headquarters: 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 safety, quality, and purity. Such deviations can potentially compromise the effectiveness or safety of the drug product.

Source

Information provided by the U.S. Food and Drug Administration (FDA) under recall number D-0377-2026.

Original source: FDA Official Notice ↗

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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 Children's Healthcare of Atlanta Instant Hand Sanitizing Wipes due to 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.