FDA: Kotex tampon recall, impacted product contains infection-causing bacterium

Kimberly-Clark is recalling Kotex Natural Balance* Security Unscented Tampons Regular Absorbency, both 18 and 36 count, from a limited number of stores in several states in the United States.

The U.S. Food and Drug Administration announced that Kimberly-Clark is recalling a limited number of its Kotex Natural Balance* Security® Unscented Tampons Regular Absorbency distributed to specific stores in the United States.

This recall is limited to two product SKUs (carton codes), 15063 (18 count) and 15068 (36 count). The tampons were manufactured with a raw material contaminated with a bacterium, Enterobacter sakazakii, which may cause health risks, including vaginal infections, urinary tract infections (UTIs), pelvic inflammatory disease or infections that can be life-threatening. Women with serious existing illnesses, cancer or immune-compromised conditions, such as HIV, are at increased risk. There is limited evidence of transfer between individuals with this bacterium.

The impacted product includes both 18-count and 36-count packages of the Kotex Natural Balance* Security ® Unscented Tampons Regular Absorbency that were shipped to retail customers between October 29, 2011 and November 2, 2011 in specific Walmart stores in Iowa, Kansas, Missouri, Nebraska, New Mexico and Texas; specific Fry’s stores in Arizona; and specific Smith’s stores in Utah and Arizona. More information about the specific product SKUs and lot numbers are noted below. Not all stores in the above mentioned states were impacted. All impacted stores have been alerted to remove the recalled product SKUs from shelves. A listing of stores impacted and the latest information can also be found on the Kimberly-Clark website at www.kimberly-clark.com and the Kotex brand website at www.kotex.com.

Kotex Natural Balance* Security® Unscented Tampons Regular Absorbency Affected Lot Numbers/Carton Counts/SKUs:

  • AC129321X, 18 Count, 15063
  • AC129325X, 36 Count, 15068
  • AC129321X, 18 Count, 15063
  • AC129325X, 36 Count, 15068
  • AC129321X, 18 Count, 15063
  • AC129325X, 36 Count, 15068
  • AC129321X, 18 Count, 15063
  • AC129325X, 36 Count, 15068
  • AC129321X, 18 Count, 15063
  • AC129325X, 36 Count, 15068
  • AC129321X, 18 Count, 15063
  • AC129325X, 36 Count, 15068
  • AC129321X, 18 Count, 15063
  • AC129325X, 36 Count, 15068

Product SKU numbers 15063 and 15068 are the last five digits of the product’s barcode and can be found on the bottom of the package. Specific lot numbers can be found inside the red box located on the bottom of the package.

Consumers should contact a physician immediately if they have used the impacted Kotex Natural Balance* Security® Unscented Tampons Regular Absorbency product and experience unusual vaginal discharge, rash, fever, headache, vomiting or abdominal pains, particularly if they are HIV positive, have AIDS, cancer, an existing serious illness or may be pregnant.

If any consumer has the impacted Kotex Natural Balance* Security® Unscented Tampons Regular Absorbency in their possession, they should stop using the product immediately. They should also contact Kimberly-Clark’s Consumer Services Division at 1-800-335-6839 so the necessary information and arrangements can be made to retrieve the unused product.

While no reports of any adverse reactions from consumers using the recalled product have been received by Kimberly-Clark to date, this product recall is to maintain Kimberly-Clark’s expected high level of quality in all its products.

No other Kotex-branded products are subject to this recall, and Kotex Natural Balance* Security® Tampons that don’t contain the SKU numbers or lot numbers described in this announcement should be considered safe to use by consumers.

Image: U.S. Food and Drug Administration