CLASS I 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, (ethyl alcohol 70% v/v) Packaged as a), distributed nationwide in the US. The recall was initiated on 11 Jul 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-0031-2021
- FDA event ID
- 86022
- Recalling firm
- 4e Brands North America, San Antonio, TX
- Classification
- Class I
- 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
- Potency & Assay
- 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
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) 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, 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?
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Which lots are affected?
Lot #: a) 2141, Exp 04/40/23; 2879, Exp 04/23/23; 3005, Exp 05/08/23; b) 2911, Exp 04/23/23
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 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.
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 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 |
| Drug | CLASS II | blumen Advanced Hand Sanitizer, 70% Alcohol Content recalled | 4e Brands North America | Manufacturing (CGMP) Deviations | Nationwide |