Acme United Corporation Recalls First Aid Only BZK Antiseptic Towelettes Due to CGMP Deviations

What Happened

Acme United Corporation has initiated a voluntary Class II recall of its First Aid Only BZK Antiseptic Towelettes. The recall was prompted by Current Good Manufacturing Practice (CGMP) deviations discovered by the firm. The recall was officially initiated on January 20, 2026, and classified by the FDA on March 2, 2026.

Which Products Are Affected

The recall affects the First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk.

Product Details:

• Brand Name: First Aid Only BZK Antiseptic
• Manufacturer: Acme United Corporation
• UPC: 0092265083072
• NDC Numbers: 0924-7116-00, 0924-7116-04, 0924-7116-05, 0924-7116-03, 0924-7116-01, 0924-7116-02
• Recall Number: D-0361-2026

Affected Lot Numbers and Expiration Dates:

• MN12121, MN13521 (Exp. Apr 2026)
• MN15221, MN16721, MN16921, MN17021, MN17021B (Exp. May 2026)
• MN18521, MN18621, MN18621B (Exp. Jun 2026)
• MN24721, MN25021 (Exp. Aug 2026)
• MN27421, MN27721 (Exp. Sep 2026)
• MN31321, MN31421 (Exp. Oct 2026)
• MN34321, MN34521, MN34721 (Exp. Nov 2026)
• MN02022, MN03022 (Exp. Dec 2026)
• MN03522, MN04622 (Exp. Jan 2027)
• MN06022, MN06122 (Exp. Feb 2027)
• MN12322, MN12422, MN14422 (Exp. Apr 2027)
• MN15322 (Exp. May 2027)
• MN22022 (Exp. Jul 2027)
• MN25222, MN25322, MN26422 (Exp. Aug 2027)
• MN27822 (Exp. Sep 2027)
• MN15322, MN01123 (Exp. Nov 2027/Dec 2027)
• MN06123 (Exp. Aug 2027)
• MN06423, MN06523 (Exp. Feb 2028)
• MN09423, MN09523, MN09723, MN10223 (Exp. Mar 2028)
• MN12623, MN13323 (Exp. Apr 2028)
• MN15322, MN16523 (Exp. May 2028)
• MN18623, MN19323, MN19423, MN20223 (Exp. Jun 2028)
• MN24323, MN24423 (Exp. Jul 2028)
• MN34523 (Exp. Nov 2028)
• 301424, 301524, 301624, 301724, 303124 (Exp. Dec 2028)

What You Should Do

Consumers and distributors should immediately check their inventory for the affected lot numbers listed above. If you possess any of the recalled towelettes, you should stop using them. Acme United Corporation notified distributors via letter. For further information regarding returns or disposal, contact Acme United Corporation at their headquarters in Shelton, CT.

Why This Matters

This recall is significant because CGMP deviations indicate that the product was not manufactured in accordance with federal quality standards, which could impact the safety or efficacy of the antiseptic drug product.

Source

Information provided by the FDA.