Volu-Sol Handrub Sanitizing Solution — Class I drug recall D-0033-2021
Terminated recall by Volu-Sol, Inc., reported 2020-10-07, distributed in CA, UT. Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
| Recall number | D-0033-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volu-Sol, Inc., Salt Lake City, UT, United States |
| Recall initiated | 2020-08-14 |
| Classified | 2020-10-14 |
| Reported by FDA | 2020-10-07 |
| Terminated | 2024-02-26 |
| Distributed | CA, UT |
| Reason classes | chemical contamination, labeling, unapproved product |
| NDC | 74401-0800-16 |
| Lot numbers | WHO100, WHO101, WHO104, WHO105, WHO108, WHO109 |
| Expiration dates | 2022-04, 2022-05 |
Product
Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 7.2% v/v) Topical Solution, 473 mL/ 16 fl oz bottle, Vou-Sol 5095 W 2100 S, Salt Lake City, UT 84120, NDC 74401-800-16
Reason for recall
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
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-0033-2021. 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.