NEW YORK – Johnson & Johnson is expanding a voluntary recall of Tylenol Arthritis Caplets due to consumer reports of a moldy smell that can cause nausea and sickness.
According to a statement posted to the Food and Drug Administration Web site late Monday, the New Brunswick, N.J., company is now recalling all product lots of the Arthritis Pain Caplet 100 count bottles with the red EZ-Open Cap.
Johnson & Johnson had recalled five lots of the product last month after consumers complained of a musty, mildew-like odor that triggered nausea, stomach pain, vomiting and diarrhea.
The health care company said the odor results from trace amounts of a chemical called 2,4,6-tribromoanisole. That chemical is believed to result from the breakdown of another chemical used to treat wooden pallets that transport and store packaging materials.
To date, the side effects, which also include vomiting and diarrhea, have been "temporary and non-serious," although the health effects of the compound have not been studied.
The recall only affects the specific lots cited. All other Tylenol Arthritis pain products remain available.
The company will reintroduce Tylenol Arthritis Pain Caplets 100 count by January after moving production to a new facility.
J&J's McNeil consumer health care division sells a range of over-the-counter medicines, including cold reliever Sudafed and the antacid Mylanta. The unit posted $16 billion in sales in 2008, according to J&J's annual report.
Consumers seeking a refund or replacement can call J&J at 1-888-222-6036.