FDA DrugsClass II

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.

Publicado: 11 de marzo de 2026ID de Retiro: D-0361-2026Categoría: Medicamentos y FármacosPaís: Estados Unidos
US
PharmaceuticalFDA DrugsUSUS

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.

Recalling Firm: ACME UNITED CORPORATION

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Motivo del Retiro / Peligro

CGMP Deviations

Descripción del Producto e Identificación

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.

Additional Source Details

FieldValue
CityShelton
StateCT
Openfda › Upc0092265083072
Openfda › UniiF5UM2KM3W7
Openfda › RouteTOPICAL
Openfda › Spl id2488e41a-56e3-f4ab-e063-6394a90a2700
Openfda › Brand nameFIRST AID ONLY BZK ANTISEPTIC
Openfda › Spl set iddbed7ed6-a9b8-7b59-e053-2a95a90ac0cb
Openfda › Package ndc › 10924-7116-00
Openfda › Package ndc › 20924-7116-04
Openfda › Package ndc › 30924-7116-05
Openfda › Package ndc › 40924-7116-03
Openfda › Package ndc › 50924-7116-01
Openfda › Package ndc › 60924-7116-02
Openfda › Product ndc0924-7116
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 #: 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... [TRUNCATED]
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

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanne...?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Resumen

  • Empresa ResponsableACME UNITED CORPORATION
  • StatusOngoing
  • Nivel de RiesgoClass II
  • DistributionNationwide within the United States
Recall Hazard Severity
High Alert (Class I)
Alerta Oficial de la Agencia

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🚨 SAFETY ALERT: ACME UNITED CORPORATION - 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.

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