Class II U.S. Food and Drug Administration

Acme United Corporation Med Nap BZK Antiseptic Towelettes , 100 Towelettes recall: CGMP Deviations

Recall published 8 months ago

CGMP Deviations

The hazard: Labelling or manufacturing-practice failure

The defect here is documentary: wrong strength on the label, a mismatched barcode, or records that do not demonstrate the product was made correctly.

What the notice says: CGMP Deviations

Why it matters: The label, the strength printed on it, the barcode or the manufacturing records do not meet federal requirements. The practical danger is someone taking the wrong drug or the wrong dose while believing they have the right one.

Symptoms and when to call a doctor

If you may have taken a product that turned out to be a different drug or strength from the one on the label, call your prescriber, and call Poison Control on 1-800-222-1222 if you feel unwell. Describe what the pack said and what you actually took.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0366-2026
Published
March 11, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Acme United Corporation
Product type
Prescription & OTC drugs
Units affected
N/A
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: MN09322, Exp. Date Mar 2027; MN15222, Exp. Date May 2027; MN21622, Exp. Date Jul 2027; MN31822, Exp. Date Oct 2027; MN06223, MN06323, Exp. Date Feb 2028; MN12523, Exp. Date Apr 2028; MN16123, Exp. Date May 2028; MN20523, MN20623, MN20723, Exp. Date Jun 2028; MN23223, Exp. Date Jul 2028; MN31123, Exp. Date Oct 2028; MN300524, MN300624 MN302624, MN302724, MN303324, Exp. Date Dec 2028.

Products covered by this recall

Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01.

Check your product

The notice names 13 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • MN09322

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • Mar 2027
  • May 2027
  • Jul 2027
  • Oct 2027
  • Feb 2028
  • Apr 2028
  • May 2028
  • Jun 2028
  • Jul 2028
  • Oct 2028
  • Dec 2028. — N

NDC number

On the carton and again on the bottle or blister label.

  • 0924-0246-01

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Labelling

Acme United Corporation — The defect here is documentary: wrong strength on the label, a mismatched barcode, or records that do not demonstrate the product was made correctly.

  1. Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
  2. Return the affected pack to the pharmacy for a replacement from a good lot.
  3. Report a mismatch to FDA MedWatch, especially if it reached you rather than being caught at the counter.
  4. If what you were dispensed does not match your prescription, call the pharmacy before taking another dose.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: ACME UNITED CORPORATION — 1 Waterview Dr Ste 200, Shelton, CT, 06484-4368

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Acme United Corporation prescription & otc drugs recalled?

CGMP Deviations CGMP Deviations

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code MN09322; best-by date Mar 2027 or May 2027. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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