Hand Sanitizer Recalled for Chemical Impurities and Manufacturing Defects
SIREtizer Hand Sanitizer is recalled for containing acetal and acetaldehyde above allowable limits and manufacturing defects, including one superpotent lot.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for documented chemical contamination (acetal and acetaldehyde above allowable limits) and manufacturing defects (superpotent lot). While no illnesses have been reported, these impurities above regulatory limits in a topical product constitute a documented risk of harm.
Plain-English summary
SIREtizer Hand Sanitizer, manufactured by Southwest Iowa Renewable Energy LLC, is being recalled due to manufacturing deviations and chemical contamination. Testing found that levels of acetal and acetaldehyde in the product exceed allowable FDA limits. Additionally, lot 001 was found to be superpotent, meaning the ethanol concentration is higher than specified.
The recall affects SIREtizer Hand Sanitizer in three package sizes: 3.38 oz (100 mL), 10 oz (295 mL), and 16.9 oz (500 mL) bottles. The affected products were distributed in Iowa and Nebraska. The recall involves lots 0001, 0005, and 0007, affecting approximately 12,704 bottles total.
Consumers who have purchased SIREtizer Hand Sanitizer should stop using the product immediately. Return it to the place of purchase or dispose of it safely. If you have experienced any health effects from using this product, contact a healthcare provider.
The recalled product
- Product
- SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and c) 16.9 oz (500 ml), UPC 8 60003 85880 6 bottles, Southwest Iowa Renewable Energy, 10868 189th Street, Council Bluffs, IA 51503; Bottled by Southwest 6th…
- Manufacturer
- Southwest Iowa Renewable Energy LLC
- Category
- Drug
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 (3)
- Lots: 0001
- 0005
- 0007
Distribution
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