Johnson & Johnson's McNeil Consumer Healthcare unit received some complaints from people who reported nausea, stomach pain, vomiting and diarrhea after taking the pills, a spokeswoman said Monday.
This makes 13 recalls in barely a year by the health care giant, mostly for more serious problems with its nonprescription drugs, contact lenses, blood glucose test strips and hip implants.
It's the fifth time that the New Brunswick, N.J.-based company has recalled nonprescription medicines because of consumer complaints about an unpleasant odor.
The moldy odor is thought to be due to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole, McNeil said in a statement.
Previously, the company said the chemical was on wooden shipping pallets that it has stopped using after Jan. 15.
Asked if that was again the case with the latest recalls, J&J spokeswoman Carol Goodrich said, "We've seen both.
"Some complaints have come in from smelling the bottles and some from ingesting the pills," Goodrich said.
She could not say whether any complaints from the prior recalls had involved people ingesting the pills.
The latest recall, announced Monday, covers one lot of Tylenol 8 Hour caplets in 50-count bottles.
McNeil said the recall is precautionary and the problems reported by consumers were temporary and not serious. The company said the risk of serious harm is remote.
The first two such recalls, both late last year, involved first five lots and then all product lots of Tylenol Arthritis Pain Caplet 100 count bottles with the red EZ-Open Cap.
On Jan. 15, J&J issued a large-scale recall of containers of children's and adult Tylenol, plus Motrin, St. Joseph's aspirin, Benadryl, Rolaids and Simply Sleep, also because of a moldy smell that had made people sick. Then on July 8, the company recalled 21 lots of Benadryl, Motrin and about nearly 20 varieties of Tylenol for the same reason.
J&J did not say how many bottles are in a lot.
Rival drugmaker Pfizer Inc. also recalled a product recently because of a musty odor, pulling bottles of its top-selling cholesterol medicine Lipitor on Oct. 9.
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For more recall information: www.tylenol.com
