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  4. Kimberly-Clark Announces Voluntary Recall of U by Kotex® Sleek® Tampons, Regular Absorbency,Throughout U.S. and Canada
  1. Recalls, Market Withdrawals, & Safety Alerts


Kimberly-Clark Announces Voluntary Recall of U by Kotex® Sleek® Tampons, Regular Absorbency,Throughout U.S. and Canada

This recall has been completed and FDA has terminated this recall.

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Company Announcement Date:
FDA Publish Date:
Product Type:
Medical Devices
Obstetrical & Gynecological
Reason for Announcement:
Recall Reason Description
Unraveling and/or coming apart upon removal
Company Name:
Brand Name:
Brand Name(s)
Product Description:
Product Description

Company Announcement

Kimberly-Clark announced a voluntary product recall of its U by Kotex® Sleek® Tampons, Regular Absorbency, sold throughout the United States and Canada for a quality-related defect that could impact the performance of this product.

The recall is limited to specific lots of U by Kotex® Sleek® Tampons, Regular Absorbency, that were manufactured between October 7, 2016 and October 16, 2018 and distributed between October 17, 2016 and October 23, 2018. Consumers can identify this product by looking for specific lot numbers found on the bottom of the package. A full list of recalled lot numbers is available on the U by Kotex® website. Retailers have been alerted to remove the recalled lot numbers from shelves and post a notification in their stores.

No other U by Kotex-branded products are subject to this recall.

Kimberly-Clark has received reports from consumers of the U by Kotex® Sleek® Tampons, Regular Absorbency, unraveling and/or coming apart upon removal, and in some cases causing users to seek medical attention to remove tampon pieces left in the body. There also have been a small number of reports of infections, vaginal irritation, localized vaginal injury, and other symptoms.

Any consumer with the impacted U by Kotex® Sleek® Tampons, Regular Absorbency, in their possession should stop using the product immediately and promptly contact Kimberly-Clark's Consumer Service team at 1-888-255-3499 between 7:30 a.m. – 7:00 p.m. Central Time, Monday through Friday, for information regarding this recall. Consumers who experience vaginal injury, (pain, bleeding, or discomfort), vaginal irritation (itching or swelling), urogenital infections (bladder and/or vaginal bacterial and/or yeast infections), or other symptoms such as hot ashes, abdominal pain, nausea, or vomiting following use of the impacted product should seek immediate medical attention.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Canadian health care professionals and consumers may report device-related incidents directly to Health Canada by completing a Health Product Complaint Form online.

U by Kotex Sleek Tampons, Regular Absorbency

Impacted Lot Code Listing

18 Count Package 34 Count Package 34 Count Multipack 
(contains 17 U by Kotex 
Sleek Tampons, Regular 
3 Count 
NN628201B NN728713C NN628101A NN724713A NN629401B NN728313B XM700604X
NN628301A NN728713D NN628101B NN724713B NN629501A NN729713A XM700904X
NN628301B NN729813A NN628201A NN726713D NN631301B NN729713B XM702304X
NN629101A NN731113A NN628201B NN726813A NN631401A NN730913C XM702404X
NN629101B NN732513B NN629401A NN728213B NN631401B NN730913D XM702504X
NN629201A NN733713D NN629401B NN728313A NN632213A NN732613B  
NN630201A NN733813A NN631201B NN729613A NN632213B NN733813B  
NN630201B NN800413B NN631301A NN729613B NN703113B NN733913A  
NN630301A NN800513C NN632101B NN729713A NN703213A NN735313A  
NN632713A NN802913B NN632113B NN732513B NN705513D NN735313B  
NN632713B NN803013A NN632213A NN732613A NN706513A NN801413D  
NN634713B NN804413A NN632213B NN733913A NN706513B NN801513A  
NN634813A NN804413B NN633813D NN733913B NN706613A NN802913A  
NN635713A NN807613D NN634113B NN735213B NN706613B NN803013B  
NN635713B NN807713C NN634213A NN735313A NN708713A NN804313A  
NN701813A NN808413C NN635013B NN801413C NN708713B NN804313B  
NN701813B NN808413D NN635113C NN801413D NN711413A NN805713B  
NN701913A NN812013A NN703113A NN802813D NN711413B NN805813A  
NN703213B NN812013B NN703113B NN802913A NN713113A NN809913B  
NN705713C NN812713B NN705613C NN804213D NN713113B NN811213D  
NN705713D NN812813A NN706313C NN804313A NN713213C NN812613D  
NN705813A NN814013D NN706313D NN805813A NN713213D NN812713A  
NN707613D NN814113A NN706413C NN805813B NN714513B NN814013C  
NN707713C NN814113B NN706413D NN807513D NN714613C NN814013D  
NN711513A NN815513A NN707713C NN807613C NN716613A NN815413D  
NN711513B NN815513B NN707713D NN809913A NN719413B NN815513A  
NN715213B NN819613D NN711313C NN811213C NN719513C NN816813D  
NN715313C NN819713A NN711313D NN811213D NN720613B NN816913A  
NN715313D NN821313A NN711413A NN815413C NN720713A NN819613C  
NN716713C NN822613B NN713013B NN815413D NN724713B NN819613D  
NN716713D NN822713A NN713113A NN815513D NN724813A NN822513A  
NN718313C NN824513D NN714313B NN816813D NN726813A NN822513B  
NN720713B NN824613A NN714413A NN818113C NN726813B NN826613C  
NN723413B NN824613B NN714413B NN818113D NN726913A NN826613D  
NN723513A NN826513D NN719313B NN822413D NN728313A NN826713A  
NN724913B NN826613C NN719413A NN822513A     
NN725013A NN827813D NN722013B NN824613B     
NN726913A NN827913C NN722113A NN824713A     
NN726913B   NN722113B NN826713A     
    NN722213A NN826713B      

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SOURCE Kimberly-Clark Corporation

Related Links http://www.kimberly-clark.com

Company Contact Information

Kimberly-Clark's Consumer Service
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