Unrated Drug recall · FDA · Published August 14, 2020

Volu-Sol Handrub Sanitizing Solution Recall: Methanol Risk

Volu-Sol recalls handrub sanitizing solution due to methanol listed as inactive ingredient without FDA approval. Affected products contain specific lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0033-2021Drug Volu-Sol ›

Recall notice

Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.

Take action

Contact the company

Recalling firmVolu-Sol, Inc.5095 W 2100 S · Salt Lake City, UT 84120-1229

✎ GovInfoNow plain-language explainer

Volu-Sol is recalling its handrub sanitizing solution because it lists methanol as an inactive ingredient without proper FDA approval. This could pose a health risk if the product is used as intended. Read more at govinfonow.com/recall/36839-volu-sol-handrub-sanitizing-solution-recall-methanol-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36839-volu-sol-handrub-sanitizing-solution-recall-methanol-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0033-2021

Cite this page

“Volu-Sol Handrub Sanitizing Solution Recall: Methanol Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/36839-volu-sol-handrub-sanitizing-solution-recall-methanol-risk. Based on FDA recall #D-0033-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0033-2021%22&limit=1).

The FDA announced on August 14, 2020, that Volu-Sol, Inc. is recalling Volu-Sol Handrub Sanitizing Solution because the product lists methanol as an inactive ingredient. The agency classified the recall as Class I.

How to tell if you have it

Brand: Volu-Sol
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
NDC: 74401-800-16
Lot codes: WHO100 (Exp. Date 4/2022), WHO101 (Exp. Date 4/2022), WHO104, WHO105, WHO108, WHO109 (Exp. Date 05/2022)
Sold to one distributor in CA and one hospital system in UT

The hazard

The product is marketed without an approved New Drug Application or Abbreviated New Drug Application. The label incorrectly lists methanol as an inactive ingredient.

Context

GovInfoNow's records show the brand has been involved in other recent recalls of similar products, including OneSource Specialty Pharma Methohexital Sodium Recall (2026-06-07) and Novadoz Glycopyrrolate Oral Solution Recall (2025-12-15). Other recent recalls of similar products include Zydus Mirabegron 25mg Tablets Recall (2026-08-05).

How to tell if you have this one

Check for the product name 'Volu-Sol Handrub Sanitizing Solution' with lot numbers WHO100, WHO101, WHO104, WHO105, WHO108, WHO109 and expiration dates of April 2022 or May 2022.

Brand
Volu-Sol
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the lot numbers and expiration dates on the product label to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed in California and Utah.

FDA distribution: “Sold to one distributor located in CA and one hospital system located in UT.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Utah.

Recall timeline

FDA terminated this recall 3.5 years after the firm started it.

Aug 14, 2020Firm started the recall
Oct 7, 2020Published in FDA’s Enforcement Report
Oct 14, 2020FDA classified it Class I
Feb 26, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/36839-volu-sol-handrub-sanitizing-solution-recall-methanol-risk">Volu-Sol Handrub Sanitizing Solution Recall: Methanol Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0033-2021 (August 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0033-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.