KY Jelly Recall Issued Over Products Not Properly Approved For Sale

Johnson & Johnson has recalled more than two million containers of K-Y personal lubricants, after federal health officials notified the company that they were not properly approved to be on the market. 

The company announced a K-Y Tingling Jelly recall, a K-Y Sensitive Jelly recall, and a K-Y Silk-E Vaginal Moisturizer and Personal Lubricant recall late last month, although news of the products being removed from the market was just reported by media outlets late last week.

According to a small notice placed on Johnson & Johnson’s K-Y website, the products were removed from the market because “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).”

The 510(k) approval process, often referred to as the fast-track approval process, allows approval of any medical device that is substantially equivalent to one already on the market. The program has been considered controversial because the definition of what is substantially equivalent appears to have become less and less defined over the years, and it has been used to approve major medical devices that were later found to be defective and deadly, but were never put through clinical trials before being sold.

The FDA has determined that these K-Y Tingling Jelly, Sensitive Jelly and Silk-E moisturizer have been significantly changed or modified to the point that they could no longer claim to be substantially equivalent to previously approved products. Johnson & Johnson indicates that it has no plans to bring the products back to the market.

The recall affected nearly 1.2 million units of Sensitive Jelly packed in 3 oz tubes with a UPC code of 380040085503. The recall also affects about 425,000 units of K-Y Tingling Jelly sold in 5 oz. tubes with a UPC code of 380040088887. The Silk-E recall affects more than 750,000 2.5 oz tubes packed in printed cartons with a UPC code of 380040087149 printed on the carton.

There are no known health risks associated with any of the recalled products, and consumers have not been directed to stop using them. However, the products have been removed from store shelves and will no longer be available for sale.