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.
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 2/5 (Moderate).
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
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
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Charles Paint Research Inc 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 2 products in this recall →Related recalls
Same manufacturer · Charles Paint Research Inc
See all →- ModerateHand Sanitizer 80% Alcohol Recall Due to Acetaldehyde Contamination
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