Recall for Tylenol, Motrin and Other Drugs Issued Due to Moldy Smell

Johnson & Johnson has expanded a Tylenol recall issued last month, to include Motrin, Rolaids, Benadryl and a number of children’s products because of a moldy smell caused by chemical contamination, which has sickened dozens of people.

The expanded Johnson & Johnson drug recall was issued on Friday, as FDA officials criticized the company for failing to promptly investigate the problems and issue the recall, noting that Johnson & Johnson has been receiving consumer complaints since 2008. In a warning letter issued last week, the FDA called the company’s investigation and response to the problem unjustifiable. The most recent recall came only after the FDA, which does not have the authority to force a mandatory recall, pressured the company.

The recalled products include Children’s Motrin, Children’s Tylenol, Motrin IB, Benadryl, Rolaids, Simply Sleep, St. Joseph’s Aspirin and a number of Tylenol products, including Tylenol Arthritis, Tylenol PM, and 8-hour Tylenol. About 500 lots in all of the drugs were recalled in the U.S., the United Arab Emirates and Fiji. A full list of the recalled products (PDF) is available from the FDA.

The drugs have been contaminated with a chemical called 2,4,6-tribromoanisole, which is believed to come from a pesticide and flame retardant used to treat wooden pallets. The FDA reports that about 70 people have complained of moldy smells from the medicines, many of whom experienced signs of gastrointestinal distress including nausea, stomach pain, vomiting and diarrhea.

The recall is an expansion of a prior Tylenol caplet recall issued late last year for the same problem. That recall was limited to Tylenol Arthritis Pain Caplets sold in 100-count bottles with a red EZ-Open cap.

On Friday, the FDA issued a warning letter to McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, saying that the company had failed to properly investigate numerous complaints, failed to expand its investigation when it knew cross contamination was possible and had to be pushed to recall products for consumer safety.

“Your initial investigation into the root cause of the odor was unjustifiably delayed and terminated prematurely. Numerous complaints were received over a four month period in 2008 before they were considered a trend and before actions were initiated to determine the root cause,” the FDA warning letter states. “When microbiological testing in August 2008 did not support an initial speculation that microbial contamination was the root cause of the odor, the investigation was closed. No other possible root causes were pursued.”

The FDA said it is concerned about the company’s treatment of the problem because it raises questions about how Johnson & Johnson handles the quality, safety and integrity of its products. The company has 15 days to respond to the letter.