Foaming Hand Sanitizer Recalled for Elevated Acetaldehyde and Acetal Levels
Alpha Aromatics is recalling foaming hand sanitizer due to elevated levels of acetaldehyde and acetal above FDA specifications. The product was distributed to one account in North Carolina.
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: This FDA Class II recall involves chemical contaminants above specification limits in a consumer hand sanitizer product. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Alpha Aromatics is recalling foaming hand sanitizer with fresh mint scent in 1-gallon bottles due to manufacturing deviations. FDA analysis found the product contains acetaldehyde and acetal above specification limits.
The affected product was distributed to one account in North Carolina. Lot numbers 2020-013211 and 2020-013629 are involved in this recall. Approximately 544 one-gallon bottles are affected.
Consumers who have this product should discontinue use.
The recalled product
- Product
- FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238,
- Manufacturer
- Alpha Aromatics
- Category
- Drug — Hand Sanitizer
- Hazard
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 (2)
- Lot: 2020-013211 and 2020-013629
- No EXP date on label.
Distribution
Distributed in 1 state:
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