CLASS I Drug recall · Reported 7 Oct 2020 · FDA Enforcement Report
Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v recalled by Volu-Sol
Volu-Sol is recalling Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 2%, distributed in California, Utah. The recall was initiated on 14 Aug 2020 and the FDA has classified it as Class I.
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-0033-2021
- FDA event ID
- 86428
- Recalling firm
- Volu-Sol, Salt Lake City, UT
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 14 Aug 2020
- FDA classified
- 14 Oct 2020
- Reported
- 7 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Drug class
- Creams, Ointments & Gels
Timeline
| 14 Aug 2020 | Recall initiated by company | |
| 7 Oct 2020 | Published in enforcement report | +54 days |
| 14 Oct 2020 | Classified by FDA | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
Product as listed by the FDA
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
Where it was distributed
Sold to one distributor located in CA and one hospital system located in UT.
Questions about this recall
Is Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 2% v/v) recalled?
Yes. Volu-Sol recalled Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 2% v/v) on 14 Aug 2020. The recall is Class I and its status is Terminated. Recall number D-0033-2021.
Why was it recalled?
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
Which lots are affected?
Lot #: WHO100, WHO101, Exp. Date 4/2022; WHO104, WHO105, WHO108, WHO109, Exp. Date 05/2022
Where was it sold?
Sold to one distributor located in CA and one hospital system located in UT.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.