DeLauro on Tylenol Recall Expansion

Washington, DC— Congresswoman Rosa DeLauro (CT-3) released the following statement today in response to the expanded recall of Tylenol products.

A report by the Food and Drug Administration shows that McNeil Healthcare, LLC, the Johnson & Johnson division that manufactures Tylenol, received complaints about an uncharacteristic musty odor emanating from Tylenol Arthritis Relief Caplets in 2008. After multiple consumer complaints of stomach problems, a recall was initiated in September of 2009. The FDA investigated, and has determined that the quality control testing at McNeil failed, as did the company's response and notification of the public.

McNeil determined that there was no presence of microorganisms in the product, but failed to test for a chemical contamination. That failure proved hazardous when it was determined that a chemical called 2,4,6-tribromoanisole (TBA), which is the result of a breakdown of a chemical in the wood pallets used in transporting storing the packaging of the products.

Today, the company expanded the recall to include multiple over-the-counter medications, including products such as Tylenol Extra Strength, Motrin, Rolaids, Benedryl. More than 60 million bottles, spanning 27 different products, are now subject to this recall.

Congresswoman DeLauro said, "This is a serious breech in not only product safety, but in the company's response to known problems. McNeil Healthcare, and as such, Johnson & Johnson, were aware of these problems as far back as 2008. Millions of Americans have these unsafe products in their homes, and may have had them there for months. That they are just recalling these products now is completely unacceptable. These failings vividly demonstrate the need for the FDA to have mandatory recall authority for food and drugs."

Consumers seeking more information on this recall can visit the company's website at https://www.mcneilproductrecall.com/, or the FDA's MedWatch website, https://www.fda.gov/Safety/MedWatch/default.htm.