Skip to main content

FDA Expands McNeil OTC Drug Recall, Rebukes Manufacturer for Yearlong Delay

By January 22, 2010July 17th, 2019Dangerous Drugs

As a dangerous drug attorney, I have watched the recall of McNeil Pharmaceuticals products with interest. McNeil, a unit of Johnson & Johnson, has recalled multiple over-the-counter pain relievers because of a “musty” smell believed to be caused by a chemical used in shipping pallets, called 2,4,6-tribromoanisole (TBA). Consumers have reported stomach pain, nausea, vomiting and diarrhea after taking the tainted drugs. After finding trace amounts of TBA in Tylenol Arthritis Caplets, McNeil recalled some lots of that drug. It expanded the recall in December to include all lots, and again in early January to include multiple major OTC brands. Perhaps more importantly, the FDA sharply rebuked McNeil in a Jan. 15 warning letter for failing to fully investigate complaints about the odor or notify the FDA, despite receiving the first complaints in early 2008.
Consumers can find a list of the recalled drugs on the FDA’s Web site and learn more at
TBA is a flame retardant and pesticide. It is not well studied, but was not proven to cause harm to humans before this recall. According to a Jan. 15 Associated Press article, 70 consumers have complained to the FDA about the smell or an illness related to a TBA-tainted McNeil product. According to the warning letter, an FDA investigation of McNeil’s Puerto Rico manufacturing facility found that McNeil began receiving complaints over four months in 2008. Nonetheless, McNeil stopped its investigation after tests failed to find microbial contamination. The FDA called this decision, and the failure to look for other causes, premature and unjustified. Further complaints let to tests that fingered TBA, but the FDA said McNeil didn’t test drugs other than specific lots of Tylenol Arthritis Caplets for the chemical. Nor did it submit a report to the FDA within three working days of identifying the problem, as required by law — instead, it waited at least a year.
The FDA’s letter raises disturbing questions for pharmaceutical liability lawyers like me. The recall currently includes more than 50 million bottles of popular over-the counter products, including Tylenol, Rolaids, Motrin and St. Joseph Aspirin. McNeil’s apparent year-long delay in addressing the problem means millions of consumers were likely exposed to TBA, possibly multiple times. It’s not clear what effect that might have on them, but the gastrointestinal reaction by some consumers, and the fact that it’s poorly studied, suggests that it’s better to stay away. If later investigations show that McNeil failed to take quick action on a serious health threat, the company could face thousands of lawsuits from sickened consumers.

Carey, Danis & Lowe has a special practice representing people who have been sickened or injured by medications they thought they could trust. Under the law, drug manufacturers have the same obligation to avoid serious safety defects that all manufacturers have. But when drug companies fail, patients can end up voluntarily taking drugs that actually make them sicker. Our defective drug attorneys help victims of these unsafe medications recover compensation for the drugs’ negative effects on their lives. In a lawsuit, victims can claim money to pay all of the medical bills and other costs of the injury, along with compensation for their pain, suffering and any disability or death. Based in St. Louis and Belleville, Ill., we represent clients throughout the United States.
If you were hurt by a drug you thought would help you, the Lowe Law Firm can help. To set up a free, confidential evaluation of your case, please contact us through the Internet or call 1-877-678-3400 toll-free today.