CLASS II ONGOING Drug recall · Reported 15 Oct 2025 · FDA Enforcement Report
Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based recalled
Acuity Specialty Products is recalling Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, distributed nationwide in the US. The recall was initiated on 29 Sep 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0004-2026
- FDA event ID
- 97688
- Recalling firm
- Acuity Specialty Products, Chambersburg, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Sep 2025
- FDA classified
- 6 Oct 2025
- Reported
- 15 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Hand Sanitizer
Timeline
| 29 Sep 2025 | Recall initiated by company | |
| 6 Oct 2025 | Classified by FDA | +7 days |
| 15 Oct 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot # C2427010, Exp 9/26/2025; Lot # C2432621, Exp 11/21/2025; Lot # C2501514, Exp 1/15/2026; Lot # C2508606, Exp 3/27/2026.
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97688This product is part of a recall event; the main page for the event is AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515) recalled | Acuity Specialty Products | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Acuity Specialty Products
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515) recalled | Acuity Specialty Products | Manufacturing (CGMP) Deviations | Nationwide |