ACME UNITED CORPORATION Recalls Dynarex Obstetrical Towelettes Cleanser Due to CGMP Deviations

Source: FDA · United States

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ACME UNITED CORPORATION has initiated a voluntary Class II recall of Dynarex Obstetrical Towelettes Cleanser due to deviations from Current Good Manufacturing Practice (CGMP) standards.

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 has voluntarily initiated a recall of Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%). 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 Dynarex Obstetrical Towelettes Cleanser, packaged in boxes of 100 packets (5" x 7"). The following specific details identify the affected products:

  • Brand Name: Dynarex
  • Product Description: Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%)
  • NDC Number: 67777-244-02
  • Lot Numbers: 52347-R, 52348-R, 52349-R, 52350-R, 52351-R, 52352-R, 53518, 53519
  • Expiration Date: March 2027
  • Recall Number: D-0369-2026

These products were distributed nationwide within the United States.

What You Should Do

Consumers and healthcare providers should immediately stop using the affected lots of Dynarex Obstetrical Towelettes. For further information regarding returns or disposal instructions, contact ACME UNITED CORPORATION at 1 Waterview Dr Ste 200, Shelton, CT 06484-4368.

Why This Matters

A Class II recall indicates that the use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. In this case, the recall ensures that products not meeting manufacturing standards are removed from the market.

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 initiated a voluntary Class II recall of Dynarex Obstetrical Towelettes Cleanser due to deviations from Current Good Manufacturing Practice (CGMP) standards.
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.