ACME UNITED CORPORATION Recalls Antimicrobial Alcohol Hand Wipes Due to CGMP Deviations
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ACME UNITED CORPORATION is recalling several lots of Antimicrobial Alcohol Hand Wipes distributed nationwide 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, based in Shelton, Connecticut, has initiated a voluntary recall of its Antimicrobial Alcohol Hand Wipes. The recall was prompted by Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this as a Class II recall, which was officially categorized on March 2, 2026.
Which Products Are Affected
The recall involves the Antimicrobial Alcohol Hand Wipe (Isopropyl Alcohol 70%), manufactured for Custom Packaging Co., Inc. (Louisville, KY) with NDC 0924-251-00.
The following lot numbers and expiration dates are affected:
- Lot MN15423, MN16422: Expiration April 2027
- Lot MN26322: Expiration August 2027
- Lot MN03423: Expiration January 2028
- Lot MN09722: Expiration March 2027
- Lot MN31722: Expiration October 2027
- Lot MN15722, MN13722: Expiration April 2027
These products were distributed nationwide within the United States.
What You Should Do
Consumers should immediately check the lot numbers on their product packaging. If the product is part of the recalled lots, it should not be used. ACME UNITED CORPORATION initiated the notification process via letter on January 20, 2026. Consumers seeking further information regarding the return or disposal of these products should contact the recalling firm at their Shelton, CT address.
Why This Matters
This recall is significant because CGMP deviations indicate that the manufacturing process did not meet the required regulatory standards to ensure the product's quality, safety, and consistency.
Source
Information provided by the FDA. Recall Number: D-0378-2026.
Original source: FDA Official Notice ↗
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