Home/Recalls/FDA-D-0370-2026
FDA DrugsClass II

Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-...

Published: March 11, 2026Recall ID: D-0370-2026Category: drugsCountry: US

Reason for Recall / Hazard

CGMP Deviations

Product Description & Identification

Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00.

Additional Source Details

FieldValue
CityShelton
StateCT
Openfda › Upc0092265940375
Openfda › UniiF5UM2KM3W7
Openfda › RouteTOPICAL
Openfda › Spl id268264df-026d-f205-e063-6394a90a1107
Openfda › Brand nameMED NAP CLEANSING TOWELETTE
Openfda › Spl set idd92cd45a-234c-4872-e053-2a95a90a3e1c
Openfda › Package ndc › 10924-0243-00
Openfda › Package ndc › 20924-0243-01
Openfda › Product ndc0924-0243
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 #: MN15923, Exp. Date May 2028; MN25822, Exp. Date Aug 2027.
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