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Drug FDA Class II Ongoing cGMP deviation

First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Made in USA, NDC 0924-7116-00.

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)

First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Made in USA, NDC 0924-7116-00.

FIRST AID ONLY BZK ANTISEPTIC · N/A

NDC: 0924-7116, 0924-7116-00, 0924-7116-04, 0924-7116-05, 0924-7116-03, 0924-7116-01, 0924-7116-02
Code info: Lot #: MN12121, MN13521, Exp. Date Apr 2026; MN15221, MN16721, MN16921, MN17021, MN17021B, Exp. Date May 2026; MN18521, MN18621, MN18621B, Exp. Date Jun 2026; MN24721, MN25021, Exp. Date Aug 2026; MN01123, Exp. Date Dec 2027; MN27421, MN27721, Exp. Date Sep 2026; MN31321, MN31421, Exp. Date Oct 2026; MN34321, MN34521, MN34721, Exp. Date Nov 2026; MN02022, MN03022, Exp. Date Dec 2026; MN03522, MN04622, Exp. Date Jan 2027; MN06022, MN06122, Exp. Date Feb 2027; MN12322, MN12422, MN14422, Exp. Date Apr 2027; MN15322, Exp. May 2027; MN22022, Exp. Date Jul 2027; MN25222, MN25322, MN26422, Exp. Date Aug 2027; MN27822, Exp. Date Sep 2027; MN15322, Exp. Date Nov 2027; MN06123, Exp. Date Aug 2027; MN06423, MN06523, Exp. Date Feb 2028; MN09423, MN09523, MN09723, MN10223 Exp Date Mar 2028; MN12623, MN13323, Exp. Date Apr 2028; MN15322, MN16523, Exp. Date May 2028; MN18623, MN19323, MN19423, MN20223, Exp. Date Jun 2028; MN24323, MN24423 Exp. Date Jul 2028; MN34523, Exp. Date Nov 2028; 301424, 301524, 301624, 301724, 303124, Exp. Date Dec 2028.

Affected areas

Nationwide

Timeline

  1. Initiated
    Jan 20, 2026
  2. Published
    Mar 11, 2026
Recall number
D-0361-2026
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.