Additional Lots of Tylenol, Benadryl and Motrin Recalled Over Musty Smell

Johnson & Johnson has recalled additional lots of over-the-counter drugs that may be contaminated with a wood treatment chemical, which could cause some of the medications to have a musty smell and potentially cause illness.

This is the third expansion of an over-the-counter drug recall that was issued as a result of these problems. The latest recall was announced this week for 21 additional lots of the drugs sold in the U.S., Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago and Jamaica. It includes lots of Benadry Allergy Ultratab, Children’s Tylenol Meltaways Bubblegum, Motrin IB Caplets, Tylenol PM, and Tylenol Extra Strength in EZ Tablets, Cool Caplets, Rapid Release Gelcaps and Day & Night Value Packs. A full list of lot numbers and brands is available in the FDA announcement.

The original Johnson & Johnson drug recall was issued in December 2009 by its McNeil Consumer Healthcare subsidiary for all lots of Tylenol Arthritis Pain Caplet, 100 count bottles, due to contamination by trace amounts of a chemical called 2,4,6-tribromoanisole, or TBA, which seeped into bottles from wood pallets treated with pesticide. The contaminated drugs had a moldy smell and made some users sick.

According to McNeil Consumer Healthcare, the new lots were added to the recall as a precaution because they were found to be shipped on the same types of wood pallets that led to the contamination.

Along with a massive children’s liquid medication recall issued by McNeil earlier this year, Johnson & Johnson has faced a number of problems with quality control at their production plants, resulting in warning letters from the FDA and congressional scrutiny.

The children’s drug recall affected 136 million bottles of children’s medications, and resulted in the shutdown of the company’s Ft. Washington, Pennsylvania, plant, and the suspension of the production of all of McNeil’s children medications. Following that recall, the FDA has received nearly 800 complaints, including at least seven reports of deaths associated with the medication. However, the FDA says its investigations so far have not directly linked any of the recalled products to any of the deaths.

Some lawmakers, who have started a congressional investigation into Johnson & Johnson’s drug manufacturing activities, are now pushing for expanded FDA power to force drug recalls to help the agency quickly deal with future drug contamination problems.