Agency classClass IIOur severity:Severe FDA (Drugs)·D-1415-2012·Announced 2012-07-18

Kleenex Foam Hand Sanitizer Recalled for Microbial Contamination

Kimberly-Clark is recalling specific lots of Kleenex Foam Hand Sanitizer, Alcohol Free, due to contamination with Burkholderia cepacia complex.

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 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 recall is classified as FDA Class II and involves microbial contamination with Burkholderia cepacia complex, which is a high-risk pathogen associated with serious infections, particularly in immunocompromised individuals.

Plain-English summary

Kimberly-Clark Corporation is recalling specific lots of Kleenex Foam Hand Sanitizer, Alcohol Free, in 1.5 fl oz, 8 fl oz, and 16 fl oz bottles. The recall involves 8,994 bottles distributed nationwide and in Canada.

The affected lots were found to be contaminated with the bacterium Burkholderia cepacia complex. The FDA has classified this recall as Class II, indicating a situation that may cause temporary or medically reversible adverse health consequences.

Consumers should check their bottles for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact Kimberly-Clark for instructions on return or disposal.

The recalled product

Product: Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl oz. (236mL) , and c) 16 fl oz (473mL) bottles, Distributed by Kimberly Clark, LLC, Roswell, GA 30076
Manufacturer: Kimberly-Clark Corporation
Category: Consumer Product — Personal Care
Hazard: microbial-contamination
infection
Affected units: 8,994

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 (19)

a) SKU 34136-00
Lot #: SA2137SLA
SA2136SLB
Exp 05/13
SA2060SLB
Exp 02/14
SA2076SLB
SA2086SLC
SA2087SLA Exp 03/14
SA2131SLA
SA2135SLA
Exp 05/14 b) SKU 34135-00
Lot #: SA2086SLB
Exp 03/14 c) SKU 34111-00
Lot #: SA2086SLA
Exp 03/14
SA2122SLA
SA2123SLA
Exp 04/14

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Kimberly-Clark Corporation 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 →

Same manufacturer · Kimberly-Clark Corporation

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Same hazard · microbial contamination