CLASS II Drug recall · Reported 18 Jul 2012 · FDA Enforcement Report
Kleenex Luxury Foam Hand Sanitizer recalled by Kimberly-Clark
Kimberly-Clark is recalling Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a), b) Cassettes, 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
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-1414-2012
- 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 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
Where it was distributed
Nationwide and Canada
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?
SKU #12977-00 (Cassette - 1 Liter), Lot #: SA1229ANB; b) SKU #12979-00 (E-Cassette - 1.2 Liters), Lot #: SA1229ANA, Exp 08/13
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Kleenex Foam Hand Sanitizer, Alcohol Free in a) , b) , and c) recalled | Kimberly-Clark | Sterility | Nationwide |
More recalls from Kimberly-Clark
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|---|---|---|---|---|---|
| Drug | CLASS II | Scott¿ Moisturizing Foam Hand Sanitizer recalled by Kimberly-Clark | Kimberly-Clark | Labeling Errors | Nationwide |
| Device | CLASS II | U by Kotex¿ Sleek¿, Regular Tampons recalled by Kimberly-Clark | Kimberly-Clark | Other | Nationwide |
| Device | CLASS II | U by Kotex¿ Sleek¿, Regular/Super Tampons Multipack recalled | Kimberly-Clark | Other | Nationwide |
| Device | CLASS II | U by Kotex¿ Sleek¿, Regular Tampons recalled by Kimberly-Clark | Kimberly-Clark | Other | Nationwide |
| Device | CLASS II | U by Kotex¿ Sleek¿, Regular Tampons recalled by Kimberly-Clark | Kimberly-Clark | Other | Nationwide |