Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Co
Summary
The FDA issued a Class II for Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packe by ACME UNITED CORPORATION. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0369-2026
Action Date
2026-03-11
Status
Ongoing
Category
drug
Product Description
Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02
Lot/Code Info: Lot #: 52347-R, 52348-R, 52349-R, 52350-R, 52351-R, 52352-R, 53518, 53519, Exp. Date Mar 2027.
Quantity Affected: N/A
Reason for Recall
CGMP Deviations
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-20
Company
Shelton, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 85 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
ACME UNITED CORPORATION has 22 FDA actions in our database, including 22 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ACME UNITED CORPORATION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ACME UNITED CORPORATION have FDA actions?
ACME UNITED CORPORATION has 22 FDA actions in our database, including 22 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0369-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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