Class II — Moderate Risk Severity Status: Ongoing Authority: FDA

1) BZK Antiseptic Towelettes

Recalling Firm / Manufacturer: ACME UNITED CORPORATION (Shelton, CT, United States)
FDA Recall Number: D-0362-2026
View FDA Source
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
1) BZK Antiseptic Towelettes
Generic Name
Not provided by source
Active Substance(s)
Not provided by source
Administration Route
Not provided by source
National Drug Code (NDC)
Not provided by source
Total Quantity Recalled
N/A
Official Reason for Recall
Specific hazard or quality defect cited by the FDA

According to the official FDA enforcement report:

CGMP Deviations

Full Product Description
Packaging specifications and labeling details

1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 2) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Touchpoint, 1000 ea Bulk, Made in USA for : Food Service Resources, Flowery Branch, GA 30542. NDC 0924-7130-00. 3) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Wellstar Cobb Hand Wipes, 1000 ea Bulk, Made in the USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 4) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" FSR Sanitizing Hand Wipes, 1000 ea Bulk, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. Inner Packaging - Instant Hand Sanitizing Wipes 5) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x7" Children's 1000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542 NDC 0924-713-00. Inner packaging -Children's Healthcare of Atlanta

Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
March 11, 2026
Firm Initiation Date
January 20, 2026
FDA Classification Date
Mar 02, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
1) Lot #: MN22222, Exp. Date Jul 2027; MN05523, Exp. Date Jan 2028; MN32023, Exp. Date Oct 2028; MN15523, Exp. Date May 2028. 2) Lots MN11422B, MN11422, Exp. Date Mar 2027; MN03823, Exp. Date Jan 2028; MN09223 Exp. Date Mar 2028; MN32123, Exp. Date Oct 2028; MN20323, Exp. Date Jun 2028; MN30822 Exp. Date Oct 2027; MN304024, Exp. Date Dec 2028; MN13023, Exp. Date Apr 2028; MN12222 Exp. Date Apr 2027-Apr; MN16023, Exp. Date May 2028; MN27423, Exp. Date Aug 2028. 3) Lot #: MN304024, Exp. Date Dec 2028; MN13023, Exp. Date Apr 2028; MN12222, Exp. Date Apr 2027; MN16023, Exp. Date May 2028; MN27423, Exp. Date Aug2028. 4) Lot#: MN04423, Exp. Date Jan 2028; MN10022, Exp. Date Jul 2027; MN30722, Exp. Date Oct 2027; MN03523, Exp. Date Jan 2028; MN09323, Exp. Date Mar 2028; MN20223, Exp. Date July 2028; MN32223, Exp. Date Oct 2028 5) Lots MN12122 2027-Apr, MN27523 2028-Aug & MN30922 2027-Oct.
Distribution Information
Geographic scope of affected shipments

Nationwide within the United States

Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.

Official Source Provenance

Verified regulatory citation from U.S. FDA OpenFDA

Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0362-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508606UTCC
View Official FDA Source

System Notice

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