FDA Recall D-0361-2026

Product

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.

Lot / code: Lot #: 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, 301524, 301624, 301724, 303124, Exp. Date Dec 2028.

Quantity: N/A

Reason for recall

CGMP Deviations

Recall record

Recall number

D-0361-2026

Classification

Class II

Status

Ongoing

Voluntary or mandated

Voluntary: Firm initiated

Firm notification

Letter

Distribution

Nationwide within the United States

Recall initiated

2026-01-20

Classified by FDA Center

2026-03-02

FDA published

2026-03-11

Recalling firm

ACME UNITED CORPORATION

Firm location

Shelton, CT

Drug identification

Brand name(s)

FIRST AID ONLY BZK ANTISEPTIC

Generic name(s)

BENZALKONIUM CHLORIDE

Manufacturer(s)

Acme United Corporation

NDC(s)

0924-7116

Route(s)

TOPICAL