Expansion of McNeil OTC Recall

In November 2009, McNeil Consumer Healthcare issued a recall of some of its Tylenol Arthritis Pain Caplet 100-count bottles. Recently, the FDA announced that the McNeil recall has been expanded. The new recall includes some adult and children’s Tylenol products, Benadryl Allergy tablets, St. Joseph chewable and safety-coated aspirin, Rolaids antacid tablets, Motrin IB caplets and tablets and Simply Sleep mini-caplets. The original recall was sparked by consumer complaints of "an unusual, moldy, musty, or mildew-like odor." Though not all of the products in the expanded recall have been linked to similar complaints, according to McNeil, they all have the potential to be affected

The FDA sent McNeil a warning letter after finding out that the company became aware of the odor problem in September 2008, but did not alert the FDA until one year later. According to the FDA, McNeil should have acted more quickly and aggressively to investigate the problem. In some cases, the odor caused nausea, vomiting, stomach pain, and diarrhea. After the FDA was alerted, it urged McNeil to conduct a thorough investigation. McNeil determined that the smell was caused by a chemical formed by the breakdown of a chemical used to treat wood pallets involved in the transport and storage of packaging materials. The FDA is looking into whether the same pallets were used by other companies.