Medi-First Antiseptic Wipes Recalled Nationwide Due to Manufacturing Deviations

What Happened

Acme United Corporation has initiated a voluntary recall of Medi-First Antiseptic Wipes (Benzalkonium Chloride 0.13%). The recall was triggered by Current Good Manufacturing Practice (CGMP) deviations discovered during the manufacturing process. The FDA has classified this as a Class II recall, which was firm-initiated on January 20, 2026.

Which Products Are Affected

The recall affects Medi-First Antiseptic Wipes (BZK) packaged in boxes of 100 wipes. The products were distributed nationwide within the United States.

Product Details:

• Brand Name: MEDI-FIRST ANTISEPTIC WIPES
• Generic Name: Benzalkonium Chloride 0.13%
• NDC Numbers: 47682-122-33, 47682-122-99, 47682-122-71, 47682-252-99, 47682-252-71
• UPCs: 0347682214715, 0347682130718
• Recall Number: D-0365-2026

Affected Lot Numbers and Expiration Dates:

• Lot #: MN15922, Exp. Date: April 2027
• Lot #: MN31022, Exp. Date: October 2027
• Lot #: MN27223, Exp. Date: August 2028

What You Should Do

Consumers and healthcare providers should immediately check their inventory for the affected lot numbers listed above. If you possess any of the recalled wipes, stop using them immediately. The recalling firm, Acme United Corporation, initially notified distributors and customers via letter. For questions regarding this recall or to arrange for product returns, consumers may contact Acme United Corporation at their headquarters in Shelton, CT.

Why This Matters

This recall is significant because CGMP deviations can compromise the quality and safety standards required for over-the-counter drug products. A Class II classification indicates that the use of the product may cause temporary or medically reversible adverse health consequences.

Source

Information provided by the FDA.