Johnson & Johnson is recalling some lots of infants' and children's Tylenol because of a possible bacterial contamination of the pain and fever treatment.
Tylenol products being recalled were manufactured between April and June 2008, the health care giant said.
The company identified 21 varieties of the products, which come in various flavors and forms, and 57 different lot numbers, affected by the recall.
The company said it had contacted wholesalers and retailers about the recall, which affects only the United States. It was not immediately clear how widely distributed the 57 affected lots were within the US.
In a letter dated September 18, J&J unit McNeil Consumer Healthcare said that after consulting with the US Food and Drug Administration, it initiated the voluntary recall.
It said the likelihood of a medical problem arising was remote.