ACME UNITED CORPORATION Recalls Dynarex Obstetrical Towelettes Cleanser Due to CGMP Deviations
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 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.
Source: FDA Official Notice