HIGHFDA DRUG

Dynarex BZK Antiseptic Towelettes 1000-Pack Recalled for CGMP Deviations (2026)

Dynarex recalled 1,000-pack BZK Antiseptic Towelettes nationwide after CGMP Deviations were identified. The product contains benzalkonium chloride 0.13% and carries NDC 67777-245-04. Consumers should stop using this product immediately and await recall notification by letter.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
January 20, 2026
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
January 20, 2026
Hazard Level
HIGH
Brands
Dynex, BZK PADS
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Dynex, BZK PADS
Product type
BZK Antiseptic Towelettes
Model numbers
53518, 53519
UPC codes
67777-245, 67777-245-01, 67777-245-11, 67777-245-02, 67777-245-14, 67777-245-04, 67777-245-15, 67777-245-05 +3 more
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    January 20, 2026

  2. Reported by FDA DRUG

    March 11, 2026

  3. RecallRadar source check

    April 13, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

CGMP Deviations

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact ACME UNITED CORPORATION or your healthcare provider for guidance. Notification method: Letter

About This Product

BZK antiseptic towelettes are used for surface cleansing and wound care in clinical and home settings. They are sold in large quantities for healthcare facilities and consumer use.

Why This Is Dangerous

CGMP Deviations indicate manufacturing quality controls did not meet standard guidelines. This can raise questions about product consistency and safety.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

Consumers in the United States may have products that require inspection and potential return. The recall is high risk because it involves a drug-like antiseptic product and CGMP quality concerns.

Practical Guidance

How to identify if yours is affected

  1. Locate NDC 67777-245-04 on packaging.
  2. Check Lot numbers 53518 or 53519.
  3. Verify expiration date Jun 2027.

Where to find product info

Refer to the FDA recall page for D-0376-2026 and the official notice from Dynarex.

What timeline to expect

Expect recall-related communications by letter. Refund or replacement timelines, if offered, commonly run 4-8 weeks after submission.

If the manufacturer is unresponsive

  • Document all attempts to contact the provider.
  • Escalate to the FDA recall office if the company is unresponsive.
  • Consult a healthcare professional for alternative antiseptic products in the interim.

How to prevent similar issues

  • Always verify NDCs and lot numbers before reuse.
  • Purchase antiseptic products only from reputable retailers.
  • Keep an eye on FDA recall notices for drug-like consumer products.

Documentation advice

Keep the recall notice, product packaging, purchase receipts, and any correspondence with the company as records.

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Product Details

Model numbers: 53518 and 53519. NDC 67777-245-04. Pack size: 5x7 inch packaging, 1000 packets. Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA. Sold nationwide in the United States. Recall class: Class II. Recall date: 2026-01-20. Status: ACTIVE. Hazard: CGMP Deviations. Remedy: Stop using the product immediately; notification by letter.

Key Facts

  • Lot numbers 53518 and 53519
  • Exp. date Jun 2027
  • Hazard: CGMP Deviations
  • Distribution: Nationwide in the U.S.
  • Remedy: Stop use and await letter notification

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
53518
53519
UPC Codes
67777-245
67777-245-01
67777-245-11
+8 more
Affected States
ALL
Report Date
March 11, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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