The Recall Desk
HighFDA (Drugs)·D-0760-2023·Announced 2023-05-31

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.

What this means for you

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
  • acetaldehyde
  • acetal

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:

  • NC

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