Recall Alert: Mislabeled Acetaminophen Could Lead To Liver Failure

They were sold nationwide from June 12, 2015 through September 18, 2015.

Medline Industries has voluntarily recalled one lot of their 500 milligram acetaminophen tablets, because they are labelled as 325 milligram pills. The Food and Drug Administration says the Acetaminophen 500mg tablets are incorrectly labeled as 325mg tablets.

The tablets affected by the recall belong to lot number 45810. In this case, bottles are marked with the wrong strength, which creates the danger that consumers could take too much acetaminophen and suffer liver damage. The FDA said in a news release that taking the maximum labeled dose every four hours, five doses a day, or with other medications containing acetaminophen could lead to liver toxicity or liver failure. Medline Industries has not received any reports of adverse events with this product.

This error is not easily identifiable by the user or prescriber.

Acetaminophen is an over the counter oral pain reliever that is used to treat minor aches and pains associated with arthritis, muscular aches, backaches, headaches, toothaches, and the common cold. Alcohol consumption is also discouraged during drug therapy due to the risk of liver damage. The pharmaceutical firm is now investigating the root cause of the mislabeling and the necessary corrective and preventive measures.