Class II U.S. Food and Drug Administration

Acuity Specialty Products, Inc. Wyandotte, Sanifect E3, Hand Sanitizer recall: cGMP deviations: The recall was initiated because required receipt testing

Recall published 1+ years ago

cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.

The hazard: Harmful chemical exposure

The hazard here is chemical rather than mechanical, so the right response is to stop using the product and to ventilate or clean anywhere it has been applied.

What the notice says: cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.

Why it matters: A chemical that should not be present at this level was found in the product. Depending on the substance, the concern may be a burn or irritation on contact, or a long-term risk from repeated exposure.

Symptoms and when to call a doctor

For a splash or spill, rinse the skin or eyes with running water for 15 to 20 minutes and remove contaminated clothing. If the product was swallowed, or if there is any trouble breathing, call Poison Control on 1-800-222-1222, which operates free and around the clock — or 911 if the person is collapsing, struggling to breathe or unconscious. Take the container or a photo of the label with you to any appointment.

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-0004-2026
Published
October 15, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Acuity Specialty Products, Inc.
Product type
Prescription & OTC drugs
Distribution
Nationwide
Made in
United States
Lot / code info
Lot # C2427010, Exp 9/26/2025; Lot # C2432621, Exp 11/21/2025; Lot # C2501514, Exp 1/15/2026; Lot # C2508606, Exp 3/27/2026.

Products covered by this recall

Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4x1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum.

Check your product

The notice names 26 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.

  • C2427010
  • Exp 9
  • 26
  • 2025
  • C2432621
  • Exp 11
  • 21
  • C2501514
  • Exp 1
  • 15
  • 2026
  • C2508606
  • Exp 3
  • 27

Best-by / use-by date

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

  • 26
  • 2025
  • 11
  • 21
  • 15
  • 2026
  • 27

Model or item number

On the rating label, the box or the instruction sheet.

  • 5511

Package size

Match the net weight or the piece count on the front of the pack.

  • 1000 mL
  • 1 Gallon
  • 5 Gallon
  • 55 Gallon

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 Chemical

Acuity Specialty Products, Inc. — The hazard here is chemical rather than mechanical, so the right response is to stop using the product and to ventilate or clean anywhere it has been applied.

  1. Stop using the product and keep it away from children and pets.
  2. Keep the container — the lot code on it is what a refund claim and any medical follow-up both depend on.
  3. If anyone has symptoms, call Poison Control on 1-800-222-1222 rather than guessing.
  4. Do not pour it down a drain or into a bin without checking local hazardous-waste rules, and never mix it with another cleaner.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • Give it ten working days, then chase in writing and quote your claim reference.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.
  • Paid by card? A chargeback for goods that are unfit for sale is a legitimate fallback once the company has had a fair chance.

Company contact: Acuity Specialty Products, Inc. — 800 Development Ave, Chambersburg, PA, 17201-4103

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 Acuity Specialty Products, Inc. prescription & otc drugs recalled?

cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded. cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code C2427010, Exp 9, 26; best-by date 26 or 2025; model number 5511. 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?

Stop using the product and keep it away from children and pets.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Where was the recalled product sold?

It was distributed nationwide.

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