The McNeil healthcare subsidiary of pharmaceutical giant Johnson and Johnson is voluntarily recalling three versions of its K-Y Jelly line of personal lubricants. K-Y® TINGLING® Jelly, K-Y® Sensitive Jelly and K-Y® SILK-E® Vaginal Moisturizer and Personal Lubricant will no longer be sold. The products were removed from the shelves of pharmacies and grocery stores, and retrieved from warehouses at the end of January. Today McNeil announced that there are no "product performance issues" and that consumers may safely use whatever amount of product they have remaining.
Federal regulations are the reason behind the recall. Personal lubricants fall under the government's "medical devices" category. Medical devices that are similar enough to other medical devices do not have to undergo the FDA's rigorous approval process. However, last summer, Johnson & Johnson removed it's K-Y Liquibeads personal vaginal lubricant from store shelves because the FDA had decided that the product needed to undergo the full approval process which is both lengthy and expensive. Concern that the same fate would befall the three recalled lubricants hastened their removal from store shelves.
"This was a business-driven decision," said Samantha Lucas, McNeil spokeswoman, via email in response to questions.