Wyandotte — Class II drug recall D-0004-2026
Ongoing recall by Acuity Specialty Products, Inc., reported 2025-10-15, distributed nationwide. cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used
| Recall number | D-0004-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acuity Specialty Products, Inc., Chambersburg, PA, United States |
| Recall initiated | 2025-09-29 |
| Classified | 2025-10-06 |
| Reported by FDA | 2025-10-15 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, cgmp |
| Lot numbers | C2427010, C2432621, C2501514, C2508606 |
| Expiration dates | 2025-09-26, 2025-11-21, 2026-01-15, 2026-03-27 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0004-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.