Home/Recalls/FDA-D-0366-2026
FDA DrugsClass II

Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes,...

Published: March 11, 2026Recall ID: D-0366-2026Category: drugsCountry: US

Reason for Recall / Hazard

CGMP Deviations

Product Description & Identification

Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01.

Additional Source Details

FieldValue
CityShelton
StateCT
Openfda › Upc0092265940061
Openfda › UniiF5UM2KM3W7
Openfda › RouteTOPICAL
Openfda › Spl id2682a042-f9ba-30dc-e063-6394a90a9e33
Openfda › Brand nameMED NAP BENZALKONIUM CHLORIDE ANTISEPTIC
Openfda › Spl set idd7c404c1-c765-a67c-e053-2995a90a6b8e
Openfda › Package ndc › 10924-0246-00
Openfda › Package ndc › 20924-0246-01
Openfda › Package ndc › 30924-0246-02
Openfda › Package ndc › 40924-0246-03
Openfda › Product ndc0924-0246
Openfda › Generic nameBENZALKONIUM CHLORIDE
Openfda › Product typeHUMAN OTC DRUG
Openfda › Substance nameBENZALKONIUM CHLORIDE
Openfda › Manufacturer nameAcme United Corporation
Openfda › Application numberM003
Openfda › Is original packagertrue
Event id98291
Address 11 Waterview Dr Ste 200
Address 2N/A
Code infoLot #: MN09322, Exp. Date Mar 2027; MN15222, Exp. Date May 2027; MN21622, Exp. Date Jul 2027; MN31822, Exp. Date Oct 2027; MN06223, MN06323, Exp. Date Feb 2028; MN12523, Exp. Date Apr 2028; MN16123, Exp. Date May 2028; MN20523, MN20623, MN20723, Exp. Date Jun 2028; MN23223, Exp. Date Jul 2028; MN31123, Exp. Date Oct 2028; MN300524, MN300624 MN302624, MN302724, MN303324, Exp. Date Dec 2028.
Postal code06484-4368
Report date20260311
Product typeDrugs
Product quantityN/A
Reason for recallCGMP Deviations
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260120
Initial firm notificationLetter
Center classification date20260302

Overview

  • Recalling FirmACME UNITED CORPORATION
  • StatusOngoing
  • Risk LevelClass II
  • DistributionNationwide within the United States
Official Agency Alert