Agency classClass IIOur severity:Severe FDA (Drugs)·D-0024-2021·Announced 2020-10-07

blumen Clear Advanced Hand Sanitizer Recalled for CGMP Deviations

4e Brands North America is recalling blumen Clear Advanced Hand Sanitizer because it was manufactured in a facility associated with methanol contamination, representing poor Current Good Manufacturing Practices.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a facility associated with methanol contamination, a toxic substance that can cause serious injury or death, fitting the 'Severe' criteria for significant injury risk or high-risk contamination.

Plain-English summary

4e Brands North America, LLC is voluntarily recalling blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL. The product is available in various bottle sizes, including 2 fl oz, 7.5 fl oz, 15.2 fl oz, 17 fl oz, 18 fl oz, 33.8 fl oz, 70 fl oz, and 1.05 gallon containers. A total of 17,359,247 bottles and pumps were distributed nationwide in the USA and in Canada.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The FDA determined that the product was manufactured in the same facility as another product found to contain methanol. This association represents poor CGMP, even though the source text does not explicitly state that the recalled blumen product itself was tested positive for methanol.

Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions. The product was made in Mexico and distributed by 4e Brands North America, LLC, located in San Antonio, Texas.

The recalled product

Product: blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4 c) 15.2 fl oz (450 ml) bottle, UPC 8 14266 02392 1, d) 17 fl oz / 503 ml bottle with blue…
Manufacturer: 4e Brands North America, Llc
Category: Drug — Hand Sanitizer
Hazard: methanol
cgmp-deviation
Affected units: 17,359,247

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All lots within expiry.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by 4e Brands North America, Llc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Same manufacturer · 4e Brands North America, Llc

See all →

Critical
Blumen Hand Sanitizer Recalled for Methanol and Low Ethanol Content
FDA (Drugs) · 2020-10-07
Critical
Blumen Hand Sanitizer Recalled for Methanol and Low Alcohol Content
FDA (Drugs) · 2020-10-07
Severe
Modesa Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
FDA (Drugs) · 2020-10-07
Severe
Blumen Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
FDA (Drugs) · 2020-10-07
Severe
ASSURED Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
FDA (Drugs) · 2020-10-07

Same hazard · methanol