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