Mucinex Recall Issued Over Acetaminophen Labeling Error

About 1.5 million bottles of liquid Mucinex Fast-Max are being recalled due to manufacturing problems, where the back labels may not indicate that the drug contains acetaminophen and other ingredients.

The Mucinex Fast-Max recall was announced on Tuesday by RB (formerly Reckitt Benckiser), after the company confirmed a retailer’s report that the back label information did not match the front. While no illnesses or injuries have been linked to the recalled cold medications, this could cause problems for users taking other medications containing similar ingredients.

“This missing labeling could cause the consumer to be unaware of side effects and/or risks associated with the ingestion of certain product ingredients which include Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine and/or Diphenhydramine,” the company’s announcement warns. “The voluntary recall is being issued nationwide as a precautionary measure to ensure our consumers have all relevant facts and warnings for the active ingredients contained in the bottle.”

The recall involves 135 lots of Mucinex Fast-Max Night-time Cold & Flu Liquid, Mucinex Fast-Max Cold & Sinus Liquid, Mucinex Fast-Max Severe Congestion & Cough Liquid, Mucinex Fast-Max Cold, Flu & Sore Throat Liquid, Mucinex Fast-Max Liquid Combination – Day Night Severe Cold and Night-Time Cold & Flu, and Mucinex Fast-Max Liquid combination packs – Daytime Severe Congestion & Cough Night-Time Cold & Flu. Full details, expiration dates and lot numbers can be found in the recall notice.

The recall comes amid increased concerns over the side effects of acetaminophen, which can include liver damage and even liver failure when excessive doses are received.

Acetaminophen is the most commonly used analgesic painkiller in the world, and is generally believed to be a safe medication. However, in recent years concerns have grown over the risk of liver damage from acetaminophen overdoses, which can result in liver failure and the need for a liver transplant. It has also been liked to dangerous skin reactions, like Stephens-Johnson Syndrome.

The FDA has indicated that Tylenol and other drugs containing acetaminophen may be responsible for more than 50,000 emergency room visits each year, including 25,000 hospitalizations and over 450 deaths annually.

In recent years, efforts have been ramped up to bring the risk of acetaminophen overdose to the public’s attention and to reduce the amount of liver injury cases linked to the popular analgesic, which is also found in other pain killers and a number of cold medications..

A growing number of Tylenol lawsuits are being pursued throughout the United States, alleging that the drug maker has withheld important acetaminophen safety information from the public for decades.

RB is urging consumers to safely dispose of the recalled cold medications by mixing them with an unpalatable substance like kitty litter or used coffee grounds, placing the mixture in a sealed plastic bag or other container and throwing it away in the household trash.

Consumers with questions can contact the company by calling 1-888-943-4215 or by visiting the website at www.mucinexe.com/recall.