Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0287-2022·Announced 2021-12-29

Medline Hand Sanitizer Foam Recalled for Defective Containers

Medline Industries Inc is recalling Hand Sanitizer Foam in multiple sizes due to leaking bottles and dispensing issues reported by customers. The product was distributed nationwide and internationally.

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: The FDA classified this as a Class II recall. The hazard is a defective container (leaking bottles and dispensing issues), which is a mechanical/packaging defect rather than contamination or a high-risk condition. No illnesses or injuries are reported in the source text, making this a precautionary recall based on product malfunction.

Plain-English summary

Medline Industries Inc is recalling Hand Sanitizer Foam (ethyl alcohol, 62% v/v) packaged in three sizes: 1.5 oz cans (NDC 53329-970-12), 8 oz cans (NDC 53329-970-08), and 16 oz cans (NDC 53329-970-06). The recall affects approximately 470,555 bottles distributed nationwide in the USA, Canada, Hong Kong, and Peru.

The recall is due to defective containers. Customer complaints identified leaking bottles and dispensing issues with the product. Multiple lot numbers across all three package sizes are affected, with expiration dates ranging from February 2022 through July 2023.

Consumers who have purchased affected Hand Sanitizer Foam should stop using the product and contact their healthcare provider or poison control if they have any health concerns. Customers should return the product to the retailer where it was purchased or contact Medline Industries Inc for further instructions.

The recalled product

Product: Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and c) 16 Oz. (453 g) cans, NDC 53329-970-06; Manufactured for: Medline Industries, Inc., Northfield, IL 60093.
Manufacturer: Medline Industries Inc
Category: Drug — Hand Sanitizer
Hazard: defective-container
leaking
dispensing-failure
Affected units: 470,555

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 (20)

Lot #: a) 32890
exp 04/2022
33141
33215
exp 10/2022
33350
exp 12/2022
33461
exp 03/2023
b) 32858
exp 02/2022
32889
exp 03/2022
32968
32977
32975
32984
exp 06/2022
33294
33295

Distribution

Distributed nationwide across the United States.

Same manufacturer · Medline Industries Inc

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Same hazard · defective container