J&J Expands Benadryl and Tylenol Recall Over Wood Pallet Contamination

A Tylenol recall issued last year by Johnson & Johnson due to chemical contamination has been expanded for a second time to include additional lots of Benadryl Allergy Ultratablets and Extra Strength Tylenol. 

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.

This week’s expansion of the Tylenol recall includes four lots of Benadryl Allergy Ultratab tablets in 100 count bottles sold in the U.S. with lot numbers AJA008, ADA194, ABA022 and ABA264. It also includes one lot of Extra Strength Tylenol Rapid Release Gels sold in 50-count bottles in the U.S., Trinidad and Tobago, Bermuda and Puerto Rico under lot number ASA202.

This is the second time the recall has been expanded. The first Tylenol recall expansion was issued on January 15 to include lots of Children’s Motrin, Children’s Tylenol, Motrin IB, Benadryl, Rolaids, other types of Tylenol and other products. According to the company’s press release, the latest expansion was issued because the drugs were mistakenly left out of the January 15 expanded recall.

The Tylenol contamination recall, along with the massive children’s liquid medication recall issued by McNeil earlier this year, have led to the revelation of problems with quality control at the company’s production plants which have resulted in a number of warning letters from 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. The FDA says its investigations so far have not linked any of the recalled products to any deaths, however.

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.