The Recall Desk
ModerateFDA (Drugs)·D-0792-2021·Announced 2021-09-15

Hand Sanitizer Recalled for Acetaldehyde and Acetal Above Limits

Charles Paint Research Inc is recalling 600 gallons of 80% alcohol hand sanitizer distributed in Michigan because the product contains acetaldehyde and acetal above allowable limits.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a manufacturing deviation (CGMP non-compliance). The source text does not report any illnesses or injuries related to elevated acetaldehyde and acetal levels, making this a precautionary action to prevent potential harm rather than a response to confirmed consumer injury.

Plain-English summary

Charles Paint Research Inc is recalling 600 gallons of 80% alcohol hand sanitizer (Lot# 20-160, expiration 06/11/2022) due to current good manufacturing practice (CGMP) deviations. The product contains acetaldehyde and acetal at levels above the allowable limits.

The affected hand sanitizer was distributed in Michigan. Consumers should stop using the product and follow any instructions provided by the manufacturer or retailer.

The recalled product

Product
HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131
Manufacturer
Charles Paint Research Inc
Category
Drug — Topical Antiseptic
Hazard
  • cgmp-deviation
  • acetaldehyde-contamination
  • acetal-contamination

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# 20-160
  • Exp 06/11/2022

Distribution

Distribution scope not specified by the agency.

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