Blumen Aloe Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling Blumen Aloe Advanced Hand Sanitizer because it was manufactured in a facility associated with methanol contamination, representing poor 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 and involves a facility associated with methanol contamination, a toxic substance, which aligns with the 'Severe' criteria for significant hazard potential.
Plain-English summary
4e Brands North America, LLC is recalling Blumen Aloe Advanced Hand Sanitizer, 70% alcohol content, 3.4 fl. oz./100 mL bottles. The product was distributed nationwide in the USA and in Canada. The recall involves 17,359,247 total bottles and pumps, with all lots within expiry.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The source text states that the product was manufactured in the same facility as a product found to contain methanol. This association represents poor manufacturing practices.
Consumers should stop using the product and follow instructions from the recalling firm or the FDA for disposal or return.
The recalled product
- Product
- blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL bottle, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. UPC 8 14266 02358 7
- Manufacturer
- 4e Brands North America, Llc
- Category
- Drug — Hand Sanitizer
- Hazard
- 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 →Related recalls
Same manufacturer · 4e Brands North America, Llc
See all →- CriticalBlumen Hand Sanitizer Recalled for Methanol and Low Ethanol Content
FDA (Drugs) · 2020-10-07
- CriticalBlumen Hand Sanitizer Recalled for Methanol and Low Alcohol Content
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- SevereModesa Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
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- SevereBlumen Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
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Same hazard · methanol
See all →- High
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FDA (Drugs) · 2023-06-21
- CriticalHand Sanitizer Recalled for Methanol and Acetaldehyde Contamination
FDA (Drugs) · 2023-03-15
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