KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Carton: 380040087149 Case Code: 008714 V05 Outer case UPC Code: 103800400871460055 Outer case Display UPC Code: 00380041153300
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Mc-NEIL-PPC, Inc.
Reason for Recall:
This product is not cleared for marketing in the US.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

Product Codes/Lot Numbers:

Carton: 380040087149 Case Code: 008714 V05 Outer case UPC Code: 103800400871460055 Outer case Display UPC Code: 00380041153300

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0874-2013

Related Recalls

Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device application. This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y LIQUIBEADS. JJHP received a Warning Letter on May 23, 2012 indicating that thi

Jul 2, 2012 Other Medical Devices Nationwide View Details →