ACME United Corporation Recalls Savannah Antibacterial Towelettes Due to CGMP Deviations

Source: FDA · United States

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ACME United Corporation has issued a voluntary recall for specific lots of Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%) due to manufacturing practice 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, drugs.

What Happened

ACME United Corporation, based in Shelton, CT, has initiated a voluntary recall of Savannah Antibacterial Towelettes. The recall, which has been classified as Class II by the FDA, was prompted by Current Good Manufacturing Practice (CGMP) deviations. The firm began the notification process via letter on January 20, 2026.

Which Products Are Affected

The recall affects Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), packaged as individual 4 x 7 towelettes. The products are labeled under R&R Enterprise with NDC 59647-749-02. The following lot numbers and expiration dates are included in this recall:

  • Lot #: MN24623, Exp. Date Jul 2028
  • Lot #: MN27023, Exp. Date Aug 2028
  • Lot #: MN32423, Exp. Date Oct 2028
  • Lot #: MN300724, Exp. Date Dec 2028

These products were distributed nationwide within the United States.

What You Should Do

Consumers and distributors who have these specific lots of Savannah Antibacterial Towelettes in their possession should identify the affected products by checking the lot numbers and expiration dates on the packaging. While the source data does not specify a return process, consumers typically should stop using recalled medical products and contact the recalling firm, ACME United Corporation, for further instructions regarding disposal or returns.

Why This Matters

This recall is significant because CGMP deviations indicate that the product may not have been manufactured under the strict quality and safety standards required for drug products. A Class II classification suggests that use of the product may cause temporary or medically reversible adverse health consequences.

Source

This information is provided by the FDA under recall number D-0364-2026.

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 Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%) due to manufacturing practice 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.