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Class IIOngoing

Antimicrobial Alcohol Hand Wipe recall

FDA recall D-0378-2026 · initiated Jan 20, 2026

By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Mar 11, 2026How we research

ACME UNITED CORPORATION recalled Antimicrobial Alcohol Hand Wipe in Jan 2026 — an FDA Class II recall (D-0378-2026) because CGMP Deviations.

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

CGMP Deviations

The manufacturing process itself

The FDA found the process itself out of compliance, usually before any defective product was identified.

This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.

Is your product affected? Check the lot number

A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.

Lot #: MN15423 , MN16422, Exp. Date Apr 2027-Apr; MN26322, MN26322, Exp. Date Aug 2027; MN03423, MN03423, Exp. Date Jan 2028; MN09722, Exp. Date Mar 2027; MN31722, Exp. Date Oct 2027; MN15722, MN13722 Exp. Date Apr 2027; MN31722, Exp. Date Oct 2027; MN09722, Exp. Date Mar 2027.

Quantity recalled: N/A

Details

Product
Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00.
Recalling company
ACME UNITED CORPORATION
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide within the United States
Initiated
Jan 20, 2026
FDA report date
Mar 11, 2026
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Frequently asked

Was Antimicrobial Alcohol Hand Wipe recalled?
ACME UNITED CORPORATION recalled Antimicrobial Alcohol Hand Wipe in Jan 2026 — an FDA Class II recall (D-0378-2026) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
Why was Antimicrobial Alcohol Hand Wipe recalled?
Per the FDA enforcement record, the reason for recall D-0378-2026 was: CGMP Deviations
Is a recalled Antimicrobial Alcohol Hand Wipe dangerous to take?
An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
Which lots of Antimicrobial Alcohol Hand Wipe are affected?
Distributed: Nationwide within the United States. The recall covers these lots — Lot #: MN15423 , MN16422, Exp. Date Apr 2027-Apr; MN26322, MN26322, Exp. Date Aug 2027; MN03423, MN03423, Exp. Date Jan 2028; MN09722, Exp. Date Mar 2027; MN31722, Exp. Date Oct 2027; MN15722, MN13722 Exp. Date Apr 2027; MN31722, Exp. Date Oct 2027; MN09722, Exp. Date Mar 2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0378-2026.

Source: openFDA Drug Enforcement record D-0378-2026 ↗

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