CLASS I Drug recall · Reported 30 Sep 2020 · FDA Enforcement Report
Leafree Instant Hand Sanitizer Aloe Vera recalled by Corgiomed
Corgiomed is recalling Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, distributed in Maryland, North Carolina. The recall was initiated on 3 Sep 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-1586-2020
- FDA event ID
- 86390
- Recalling firm
- Corgiomed, Mc Lean, VA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 3 Sep 2020
- FDA classified
- 18 Sep 2020
- Reported
- 30 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
- Drug class
- Hand Sanitizer
Timeline
| 3 Sep 2020 | Recall initiated by company | |
| 18 Sep 2020 | Classified by FDA | +15 days |
| 30 Sep 2020 | Published in enforcement report | +12 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 labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
Product as listed by the FDA
Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles, UPC code 6970495860325, b) 300 mL bottles, UPC code 6970495860318, and c) 500 mL bottles, UPC code 6970495860301, Exclusively Distributed by: Corgiomed LLC, McLean, VA 22102, USA, Made in China.
Where it was distributed
NC and MD
Questions about this recall
Why was it recalled?
Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
Which lots are affected?
Lot # 2020A3010, Exp 05/30/2022
Where was it sold?
NC and MD
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 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.