The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0749-2019·Announced 2019-01-23

U by Kotex Sleek Regular Tampons Recalled for Potential Breakage

Kimberly-Clark is recalling U by Kotex Sleek Regular Tampons because they may come apart upon removal.

The agency’s classification

FDA (Devices): 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 is classified as FDA Class II and involves a risk of harm (tampon breakage) without reported illnesses or injuries, fitting the High severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Kimberly-Clark Corporation is recalling U by Kotex Sleek Regular Tampons, 34 Count, due to a potential for the tampon to come apart upon removal. The recall involves 68,852,076 units distributed nationwide in the United States and internationally to Canada.

Consumers should stop using the affected tampons and check their packages for the specific lot numbers and UPC codes listed in the official recall notice. The product is identified by Package UPC 36000426649 and Case UPC 10036000426646.

This recall is classified as Class II by the FDA. Consumers with questions about the recall should contact Kimberly-Clark Corporation.

The recalled product

Product
U by Kotex¿ Sleek¿, Regular Tampons, 34 Count
Manufacturer
Kimberly-Clark Corporation
Category
Medical Device — Tampons
Hazard
Affected units
68,852,076

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 (20)

  • Package UPC: 36000426649
  • Case UPC: 10036000426646
  • Lot Numbers: NN628101A
  • NN628101B
  • NN628201A
  • NN628201B
  • NN629401A
  • NN629401B
  • NN631201B
  • NN631301A
  • NN632113B
  • NN632213A
  • NN633813D
  • NN634113B
  • NN634213A
  • NN635113C
  • NN703113A
  • NN703113B
  • NN705613C
  • NN706313C

Distribution

Distributed nationwide across the United States.

The notice also names 32 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Kimberly-Clark Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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