A generic pharmaceutical company based in Georgia is recalling concentrated drops of acetaminophen, a key ingredient in Tylenol, to help patients avoid accidentally overdosing on the product, the U.S. Food and Drug Administration said Wednesday.

Acetaminophen, a drug in Tylenol and a host of cough medicines and painkillers, is under intense scrutiny by the FDA because high-doses of the medicine are the leading cause of liver damage.

The FDA said Brookstone Pharmaceuticals LLC has voluntarily begun recalling its Concentrated Acetaminophen Drops, which are available in 16-ounce bulk containers. "The firm is recalling its product to the consumer level as a cautionary measure to minimize any confusion and potential risk to patients from dosing errors," the company said in a press release, which was posted on the FDA's Web site Wednesday.

A Brookstone representative wasn't immediately available to comment.

The FDA has been looking at liver-injury concerns associated with acetaminophen for more than 30 years. At a widely publicized FDA meeting in June, more than 30 doctors and researchers recommended new limits on dosing for acetaminophen and asked that the painkillers Percocet and Vicodin be pulled from the market. Percocet, made by Endo Pharmaceuticals Holdings Inc. (ENDP), and Abbott Laboratories' (ABT) Vicodin combine acetaminophen with other pain-killing ingredients.

About 100 people die annually from accidentally overdosing on acetaminophen, though the FDA says it is safe if taken at recommended levels. Part of the problem with dealing with liver injuries associated with acetaminophen is the drug's prevalence. Often patients don't realize they are taking an over-the-counter product and a prescription product at the same time that contain that same ingredient.

The company's recall is tied directly to confusion about dosing and the FDA's advisory panel meeting in June. "Brookstone has not received any adverse events associated with this product but due to recent advisory panel concerns, Brookstone has taken voluntary action," the company's press release said.

-By Jared A. Favole, Dow Jones Newswires; 202.862.9207; jared.favole@dowjones.com