The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1414-2012·Announced 2012-07-18

Kleenex Luxury Foam Hand Sanitizer Recalled for Microbial Contamination

Kimberly-Clark is recalling specific lots of Kleenex Luxury Foam Hand Sanitizer found to be contaminated 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk pathogen (Burkholderia cepacia complex) without reported illness, which aligns with the rubric criteria for a score of 3.

Plain-English summary

Kimberly-Clark Corporation is recalling 5,268 cassettes of Kleenex Luxury Foam Hand Sanitizer containing 0.1% Benzalkonium Chloride. The affected products are 1-liter and 1.2-liter cassettes distributed by Kimberly Clark, LLC in Roswell, Georgia.

The recall was initiated because the affected lots were found to be contaminated with the bacterium Burkholderia cepacia complex. This is a non-sterile product recall involving microbial contamination.

The affected products were distributed nationwide and in Canada. Consumers should check their products for the specific SKU and lot numbers listed in the recall notice and stop using them if they match the affected lots.

The recalled product

Product
Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz.) Cassettes, Distributed by Kimberly Clark, LLC, Roswell, GA 30076
Affected units
5,268

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 (5)

  • SKU #12977-00 (Cassette - 1 Liter)
  • Lot #: SA1229ANB
  • b) SKU #12979-00 (E-Cassette - 1.2 Liters)
  • Lot #: SA1229ANA
  • Exp 08/13

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 →

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