December 19, 2006: FDA Proposes Labeling Changes to Over-the-Counter Pain Relievers
The U.S. Food and Drug Administration (FDA) proposed to amend the labeling regulations on over-the-counter pain relievers, to include important safety information about the potential for stomach bleeding and liver damage. For products containing acetaminophen, the FDA proposed new warnings highlighting the risk of liver toxicity, and suggested that the ingredient acetaminophen be prominently displayed on the product's immediate container and on the outer carton (if applicable). Click here to read more from the FDA.

November 9, 2006: Perrigo Company Issues Voluntary Recall on Acetaminophen Caplets
Perrigo Company issued a recall for 383 lots of acetaminophen 500 mg caplets manufactured and distributed under various store-brands as a result of small metal fragments found in a small number of these caplets. Approximately 11 million bottles containing varying quantities of acetaminophen 500 mg caplets are affected by this recall. As of the time of the recall, no illnesses, injuries, or consumer complaints had been reported. More information:

• Recall Information from the Perrigo Company
• FDA News Release on the Recall (includes affected stores and products)

February 3, 2006: Consumer Group Warns About Potentially Fatal Liver Failure
In a posting on its website, national non-profit consumer advocacy Public Citizen writes that acetaminophen is linked to a large increase in cases of potentially fatal liver failure. In 2003, the FDA similarly urged consumers to exercise caution when using acetaminophen, cautioning that ingestion of too much of the painkiller could lead to serious liver damage. More information:

• Public Citizen Press Release
• FDA Consumer Magazine: Use Caution with Pain Relievers