FDA Drug Recalls

Recalls / Class II

Class IID-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.

Brand name
First Aid Only Bzk Antiseptic
Generic name
Benzalkonium Chloride
Active ingredient
Benzalkonium Chloride
Route
Topical
NDC
0924-7116
FDA application
M003
Affected lot / code info
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.

Why it was recalled

CGMP Deviations

Recalling firm

Firm
ACME UNITED CORPORATION
Manufacturer
Acme United Corporation
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
1 Waterview Dr Ste 200, N/A, Shelton, Connecticut 06484-4368

Distribution

Quantity
N/A
Distribution pattern
Nationwide within the United States

Timeline

Recall initiated
2026-01-20
FDA classified
2026-03-02
Posted by FDA
2026-03-11
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0361-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.