Blumen Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling Blumen Advanced Hand Sanitizer due to manufacturing in a facility associated with methanol contamination.
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 product manufactured in a facility associated with methanol contamination, a significant health hazard.
Plain-English summary
4e Brands North America, LLC is recalling Blumen Advanced Hand Sanitizer, 70% Alcohol Content. The product is packaged in 3.4 fl oz, 7.5 fl oz, and 33.8 fl oz bottles and was distributed nationwide in the USA and in Canada. The recall involves 17,359,247 total bottles and pumps.
The recall was initiated because the product was manufactured in the same facility as a product found to contain methanol. The FDA classifies this as a Class II recall, citing poor Current Good Manufacturing Practices (CGMP) deviations. Methanol is a toxic substance that can cause serious health issues if ingested or absorbed in significant quantities.
Consumers who have purchased this product should stop using it immediately. They should check their bottles for the UPC codes 8 14266 02359 4, 8 14266 02362 4, or 8 14266 02369 3. All lots within the expiry date are affected. Consumers should contact the recalling firm for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- 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…
- Manufacturer
- 4e Brands North America, Llc
- Category
- Consumer Product — Personal Care
- 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
FDA (Drugs) · 2020-10-07
- SevereModesa Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
FDA (Drugs) · 2020-10-07
- SevereASSURED Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
FDA (Drugs) · 2020-10-07
- SevereAssured Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
FDA (Drugs) · 2020-10-07
Same hazard · methanol
See all →- High
- CriticalFDA Recalls Alcoholada Gel Pain Reliever Over Methanol Contamination
FDA (Drugs) · 2024-05-01
- SevereHand sanitizer recalled nationwide for methanol contamination
FDA (Drugs) · 2023-06-21
- SevereHand Sanitizer Containing Methanol Recalled Due to Chemical Contamination
FDA (Drugs) · 2023-06-21
- CriticalHand Sanitizer Recalled for Methanol and Acetaldehyde Contamination
FDA (Drugs) · 2023-03-15
Similar recalls
- SevereBorn Basic Hand Sanitizer Recalled for Methanol Contamination
FDA (Drugs) · 2020-09-23
- SevereAdvance Hand Sanitizer Recalled for Methanol Contamination
FDA (Drugs) · 2021-07-07
- CriticalHand Sanitizer Recalled for Methanol Contamination — FDA Class I
FDA (Drugs) · 2022-11-23
- SevereNext Advanced Antibacterial Hand Sanitizer Recalled for Methanol Contamination
FDA (Drugs) · 2020-11-25
- SevereHand Sanitizer Product Recalled for Methanol Chemical Contamination
FDA (Drugs) · 2022-05-11
- HighAdam's Polishes Hand Sanitizer Recalled for Methanol Contamination
FDA (Drugs) · 2022-11-23