Medi-First Antiseptic Wipes Recalled Nationwide Due to Manufacturing Deviations

Source: FDA · United States

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Acme United Corporation has voluntarily recalled specific lots of Medi-First Antiseptic Wipes (Benzalkonium Chloride 0.13%) due to Current Good Manufacturing Practice (CGMP) deviations.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 2, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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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.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Acme United Corporation has voluntarily recalled specific lots of Medi-First Antiseptic Wipes (Benzalkonium Chloride 0.13%) due to Current Good Manufacturing Practice (CGMP) deviations.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.