Drug FDA Class II Ongoing cGMP deviation

BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0246-02.

ACME UNITED CORPORATION Published Mar 11, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact ACME UNITED CORPORATION or your place of purchase with questions, and see the source record below for full details.

Reason for recall

CGMP Deviations

Affected products (1)

BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5" x7", 1000 ea Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0246-02.

MED NAP BENZALKONIUM CHLORIDE ANTISEPTIC · N/A

NDC: 0924-0246, 0924-0246-00, 0924-0246-01, 0924-0246-02, 0924-0246-03

Lot codes: MN23323

Code info: Lot # MN23323, Exp. Date Jul 2028; MN31323, Exp. Date Oct 2028; MN21622, Exp. Date Jul 2027; MN13123, Exp. Date Apr 2028.

Affected areas

Nationwide

Timeline

Initiated

Jan 20, 2026
Published

Mar 11, 2026

Recall number: D-0367-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.