K-Y® Product Supply and News

K-Y® TINGLING® Jelly, K-Y® Sensitive Jelly and K-Y® SILK-E®

You may have noticed that K-Y® TINGLING® Jelly, K-Y® Sensitive Jelly and K-Y® SILK-E® Vaginal Moisturizer and Personal Lubricant are not available where you shop. That’s because these products have been recalled from wholesalers and retail stores in the United States by the manufacturer, Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. There are no safety or product performance issues related to these products and you may continue to use the products you already have purchased. No other K-Y® brand products are impacted by this recall.


If you have any questions or concerns, please call our Consumer Care Center at 1-877-414-7710 or click here for more information.

Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. is voluntarily recalling all product lots of K-Y® TINGLING® Jelly, K-Y® Sensitive Jelly and K-Y® SILK-E® Vaginal Moisturizer and Personal Lubricant from retailers and wholesalers in the United States. There are no consumer safety or product performance issues related to this recall, and consumers are not required to take any action. The company initiated this voluntary action after a detailed internal review determined that these K-Y® products may each require submission of new data to support a new medical device clearance, known as a 510(k). These products had been previously distributed as modifications to existing 510(k) cleared devices. No other K-Y® Brand products are affected by this recall.
Consumers who have questions or concerns should call our Consumer Call Center at 1-877-414-7710.




FAQ’s

Can I continue to use K-Y® TINGLING® Jelly, K-Y® Sensitive Jelly and K-Y® SILK-E® Vaginal Moisturizer and Personal Lubricant?
Yes, you may continue to use these products. There are no consumer safety or product performance issues related to K-Y® TINGLING® Jelly, K-Y® Sensitive Jelly and K-Y® SILK-E® Vaginal Moisturizer and Personal Lubricant. The product has been recalled from wholesalers and retailers, but not from consumers.

Why is this product being recalled?
An extensive review process determined that each of these three K-Y® products may require submission of new data to support a new medical device clearance, known as a 510(k). Previously, these products had been distributed as modifications to existing 510(k) cleared devices.

Is this recall temporary? Will you be bringing the products back to market?
No, we have no current plans to bring K-Y® TINGLING® Jelly, K-Y® Sensitive Jelly and K-Y® SILK-E® Vaginal Moisturizer and Personal Lubricant back to the market. We encourage you to visit www.k-y.com to learn more about other K-Y® Brand product options.

What should I do if I have these products?
You may continue using the products as directed on the label. If you have any questions or concerns, please call our Consumer Care Center at 1-877-414-7710.

Will you provide a refund?
Yes. You may contact our Consumer Care Center to request a refund at 1-877-414-7710 (Monday-Friday 8 a.m. to 8 p.m. EST).




K-Y® LIQUIBEADS®

You may have noticed that K-Y® LIQUIBEADS® is not available where you shop. This is due to a disruption in product supply. Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. has informed its retail and wholesale customers in the United States that it is voluntarily recalling all product lots of K-Y® LIQUIBEADS® Vaginal Moisturizer. This product is being recalled at the retail and wholesale level only, and not from consumers. This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y® LIQUIBEADS®. No other K-Y® brand products are impacted by this recall.

K-Y® LIQUIBEADS® is being recalled from retailers and wholesalers to address the U.S Food and Drug Administration’s (FDA) concerns that the product should be cleared under a separate medical device application. We are moving forward with the process to obtain clearance for the product.

Consumers who have questions or concerns should call our Consumer Call Center at 1-877-414-7710.




FAQ’s

Can I continue to use K-Y® LIQUIBEADS®?
Yes, you can continue to use the product. This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y® LIQUIBEADS® .

Is this recall temporary? Will you be bringing the product back to market?
Once we receive device clearance from FDA for K-Y® LIQUIBEADS®, we plan to bring it back to market as quickly as possible.

What should consumers do if they have product from this lot?
This is a retail and wholesale-level recall and not a consumer-level recall and as a result, we are not asking consumers to take any action. Consumers can continue using the product as directed on the label. If consumers have any questions or concerns, they can call our Consumer Call Center at 1-877-414-7710.

Will you provide consumers with a refund?
Yes, we will offer consumers a refund. Consumers do not need to take any action, as this is retail and wholesale-level and not a consumer-level recall. Consumers who would like to request a refund may call our Consumer Care Center at 1-877-414-7710.