Medi-First Antiseptic Wipes Recalled Nationwide Due to Manufacturing Deviations
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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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
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 ↗
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