CLASS II ONGOING Drug recall · Reported 28 Oct 2020 · FDA Enforcement Report
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution recalled
Genesis Partnership Company is recalling Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, distributed nationwide in the US. The recall was initiated on 11 Sep 2020 and the FDA has classified it as Class II.
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-0039-2021
- FDA event ID
- 86427
- Recalling firm
- Genesis Partnership Company, Villa Nueva, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Sep 2020
- FDA classified
- 19 Oct 2020
- Reported
- 28 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Creams, Ointments & Gels
Timeline
| 11 Sep 2020 | Recall initiated by company | |
| 19 Oct 2020 | Classified by FDA | +38 days |
| 28 Oct 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-04, UPC 7401037203427.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Is Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution recalled?
Yes. Genesis Partnership Company recalled Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution on 11 Sep 2020. The recall is Class II and its status is Ongoing. Recall number D-0039-2021.
Why was it recalled?
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Which lots are affected?
Lot #: 37009, Exp. 02/10/2021
Where was it sold?
Nationwide in the U.S.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from Genesis Partnership Company
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Killz Germz Hand Sanitizer, Alcohol Gel recalled | Genesis Partnership Company | Other | Nationwide |
| Drug | CLASS II | Killz Germz Hand Sanitizer, Alcohol Gel recalled | Genesis Partnership Company | Other | Nationwide |
| Drug | CLASS II | Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution recalled | Genesis Partnership Company | Sterility | Nationwide |
| Drug | CLASS II | Panagel Hand Sanitizer, 70% Alcohol recalled | Genesis Partnership Company | Foreign Material | Nationwide |
Other Genesis hand sanitizer recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution recalled | Genesis Partnership Company | Sterility | Nationwide |