Massive infant Tylenol recall

By Dr. Ananya Mandal, MDFeb 20 2012

Johnson & Johnson has announced the recall of its entire U.S. supply of infants' Tylenol—about 574,000 bottles—due to a design flaw. The flaw involved bottles of grape-flavoured infants' Tylenol, which had only just returned to shelves in November announced J&J last Friday.

With this new recall, J&J's McNeil Consumer Healthcare unit said the popular over-the-counter cold and pain remedy was safe and that it hadn't received any side-effect reports, but it acted after receiving a “small number of complaints” about a new bottle cap and dose syringe.

The cap is meant to help parents draw the right dose for babies to 2-year-olds by inserting a syringe through the cap and into the bottle. J&J introduced the cap last year, as part of a broader effort to recapture the confidence of parents. In about 17 reported instances, a part of the cap intended to restrict the flow of liquid can fall into the bottle, McNeil said in a message to parents posted on the Tylenol.com website. Parents shouldn't use the medicine if that happens, the company said.

Since2009, J&J has recalled millions of bottles of Tylenol, Benadryl, Motrin and Zyrtec as a result of such problems as metal shavings found in medicines, incorrect levels of an active ingredient and bad odours. The recalls prompted J&J to shut down a factory and have cost it more than $1 billion in lost sales.

U.S. sales at McNeil were $1.4 billion last year, 55% off the peak in 2008, the year before the recalls, according to Wells Fargo Securities. The recalls also damaged the company's reputation. Among over the counter pain medicines, Tylenol ranks eighth in loyalty, after trailing only Advil in 2009, according to the most recent survey of 49,000 adults by marketing consultant Brand Keys Inc.

J&J executives have expressed confidence recently that the worst is over. “We feel positive about where our consumer business is headed in 2012,” Chief Executive William Weldon said during an earnings call last month. In a statement on Friday, Mr. Weldon called the latest Tylenol recall “clearly disappointing after all the progress that McNeil has been making to ensure its products meet the highest level of quality and consumer satisfaction.” Mr. Weldon also said that the company issued the voluntary recall “to preserve and reinforce our commitment to patients and customers.”

McNeil spokeswoman Bonnie Jacobs said it was too soon to say when the product will return to the market. “We are looking at various alternatives for the redesign of the dosing system and will set a timeline ... once we've reviewed all the options,” she said. The company said customers can continue to use the infant Tylenol if the bottle's flow restrictor remains intact. If not, they can request a refund by contacting McNeil at 1-888-222-6036 or www.tylenol.com.