Johnson & Johnson's McNeil Consumer Healthcare is expanding its voluntary recall to include all lots of Tylenol's 100 count bottles of arthritis pain caplets because of consumer reports of an unusual moldy, musty odor.
The company voluntarily issued a recall for five lots of this same Tylenol product last year and the recall has been expanded as a precaution, according to McNeal’s press release posted on the Food and Drug Administration website.
The smell is caused by trace amounts of a chemical called 2,4,6-tribromoanisole, which is broken down by fungi from a fungicide. 2,4,6-tribromophenol is used to treat wooden pallets that transport and store packaging materials.
The nasty smell has sickened at least 70 people and triggered a number of symptoms including nausea, stomach pain, vomiting and diarrhea. Johnson &Johnson said the effects were temporary and no serious injury resulted from the exposure.
The FDA criticized the company saying that Johnson &Johnson's McNeal had known about the problem with their Tylenol products for over one year, but did not do enough to correct it in November, 2008.
The products subject to the recall include all types of products indicated for both children and adults including Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Rolaids, and Simply Sleep.