CLASS II Drug recall · Reported 7 Oct 2020 · FDA Enforcement Report
blumen Advanced Hand Sanitizer, 70% Alcohol Content recalled
4e Brands North America is recalling blumen Advanced Hand Sanitizer, 70% Alcohol Content, (70% ethyl alcohol), packaged as a), distributed nationwide in the US. The recall was initiated on 11 Jul 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-0023-2021
- FDA event ID
- 86022
- Recalling firm
- 4e Brands North America, San Antonio, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jul 2020
- FDA classified
- 7 Oct 2020
- Reported
- 7 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Hand Sanitizer
Timeline
| 11 Jul 2020 | Recall initiated by company | |
| 7 Oct 2020 | Classified by FDA | +88 days |
| 7 Oct 2020 | Published in enforcement report | +0 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: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Product as listed by the FDA
blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4 b) 7.5 fl. oz./221 ml bottle, UPC 8 14266 02362 4 b) 33.8 fl. oz./1L bottle, UPC 8 14266 02369 3, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico.
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Which lots are affected?
All lots within expiry
Where was it sold?
Distributed Nationwide in the USA
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.
Other products in this recall event
9 other products · FDA event 86022This product is part of a recall event; the main page for the event is Modesa instant Hand Sanitizer with moisturizers & vitamin E recalled.
More recalls from 4e Brands North America
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | blumen Advanced Hand Sanitizer 70% Alcohol Content recalled | 4e Brands North America | Potency & Assay | Nationwide |
| Drug | CLASS II | blumen Advanced Instant Hand Sanitizer Clear Ethyl Alcohol recalled | 4e Brands North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | blumen Aloe Advanced Hand Sanitizer 70% Alcohol Content recalled | 4e Brands North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | blumen Advanced Instant Hand Sanitizer Clear Ethyl Alcohol recalled | 4e Brands North America | Potency & Assay | Nationwide |
| Drug | CLASS I | blumen Clear Advanced Hand Sanitizer with 70% Alcohol recalled | 4e Brands North America | Potency & Assay | Nationwide |