FIRST AID ONLY BZK ANTISEPTIC
Recalling Firm / Manufacturer: ACME UNITED CORPORATION
(Shelton, CT, United States)
FDA Recall Number: D-0358-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
FIRST AID ONLY BZK ANTISEPTIC
Generic Name
BENZALKONIUM CHLORIDE
Active Substance(s)
Benzalkonium Chloride
Administration Route
Topical
National Drug Code (NDC)
0924-7116
Total Quantity Recalled
212,607,900 containers
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
CGMP Deviations
Full Product Description
Packaging specifications and labeling details
First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
March 11, 2026
Firm Initiation Date
January 20, 2026
FDA Classification Date
Mar 02, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: MN26222, MN34722, MN25922, Exp. Date Nov 2027; MN00523, MN00523, Exp. Date Dec 2027.
Distribution Information
Geographic scope of affected shipments
Nationwide within the United States
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Related Questo Medical Knowledge
Clinical cases and condition overviews related to this medication
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0358-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508606UTCC