The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0098-2021·Announced 2020-10-21

Smart Care Hand Sanitizer Recall Due to Misleading Packaging Resembling Food and Drink

The FDA is recalling Smart Care hand sanitizers because their container packaging is designed to look like food and drink pouches, potentially confusing consumers.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches"

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Smart Care hand sanitizers (Ethyl Alcohol 62%, 0.84 FL.OZ) because the container packaging is manufactured, formed, or filled to be misleading, resembling food and drink pouches. This recall affects items labeled as Paw Patrol, JoJo Siwa Dreamer, Hot Wheels, Barbie, Trolls, and Minions, distributed to California, Illinois, and Ontario, Canada. The recall is identified as D-0098-2021 and was issued by Ashtel Studios, Inc. as the recalling firm.

Consumers who have received these hand sanitizer products should stop using them immediately and dispose of them according to local regulations. The primary concern is the deceptive appearance of the packaging, which may mislead consumers into believing the product contains food or beverages rather than a hand sanitizer. Since the FDA has not reported any illnesses, injuries, or fatalities associated with this recall, the situation does not involve direct health risks to users.

The FDA emphasizes that while the product itself is not contaminated with harmful substances, the packaging design creates a safety communication gap. Consumers are advised to follow standard disposal procedures for used hand sanitizer containers and to report any concerns to the FDA. This recall falls under the category of minor labeling errors and packaging issues, consistent with a moderate severity rating.

The recalled product

Product
Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL), labeled as a) Paw Patrol (Item #: 92321-144, UPC 8 50016 92321 9, NDC 70108-042-01); b) JoJo Siwa Dreamer (Item #: 92320-144, UPC 8 50016 92320 2, NDC 70108-044-01); c) Hot Wheels (Item #…
Manufacturer
ASHTEL STUDIOS, INC.
Category
Consumer Product — 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 (1)

  • All lots codes within expiry

Distribution

Distributed in 2 states:

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