CLASS II Drug recall · Reported 18 Jul 2012 · FDA Enforcement Report

Kleenex Foam Hand Sanitizer, Alcohol Free in a) , b) , and c) recalled

Kimberly-Clark is recalling Kleenex Foam Hand Sanitizer, Alcohol Free in a) , b) , and c), distributed nationwide in the US. The recall was initiated on 14 Jun 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 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

Quantity recalled8994 Bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1415-2012
FDA event ID: 62418
Recalling firm: Kimberly-Clark, Roswell, GA
Classification: Class II
Status: Terminated
Recall initiated: 14 Jun 2012
FDA classified: 12 Jul 2012
Reported: 18 Jul 2012
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Drug class: Hand Sanitizer

Timeline

14 Jun 2012	Recall initiated by company
12 Jul 2012	Classified by FDA	+28 days
18 Jul 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Nationwide and Canada

Nationwide

Questions about this recall

Why was it recalled?

Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.

Which lots are affected?

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

Where was it sold?

Nationwide and Canada

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 62418

This product is part of a recall event; the main page for the event is Kleenex Luxury Foam Hand Sanitizer recalled by Kimberly-Clark.

Reported	Class	Recall	Company	Reason	Where
18 Jul 2012	CLASS II	Kleenex Luxury Foam Hand Sanitizer recalled by Kimberly-Clark	Kimberly-Clark	Sterility	Nationwide

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