Tylenol Recall: Musty Odor Strikes J&J Pills Again

Nearly 35,000 bottles of Tylenol are being recalled due to reports of a musty odor, which has impacted pills from Johnson & Johnson’s McNeil Consumer Healthcare division for more than a year. 

The Tylenol recall was announced on March 29 by McNeil after the company received repeated complaints from consumers about Tylenol pills having a musty smell.

The company believes that the pills may be contaminated with trace amounts of a pesticide called 2,4,6-tribromoanisole; a pesticide used to treat wood pallets where the bottles are stored while waiting for distribution. In previous cases of pesticide contamination, the pills have caused some users to suffer minor gastrointestinal illness, but there are no reports of illnesses associated with the latest recall.  

The recall affects 34,056 bottles of Tylenol 8 Hour Extended Release Caplets in 150-count bottles. The recalled Tylenol has a lot number of ADM074 and a UPC Code of 300450297181.

All of the affected Tylenol bottles were produced at McNeil’s Fort Washington, Pennsylvania manufacturing plant, which has been shut down after repeatedly failing FDA inspections. This recall is the latest of a number of pill recalls issued by Johnson & Johnson due to musty odor believed caused by pesticide contamination since late 2009, when the company announced a Tylenol Arthritis Pain Caplets recall.

That Tylenol recall was expanded three times throughout last year to include a large number of products sold throughout the U.S., Central America and the Caribbean. The recall ultimately included Benadryl, Motrin, Tylenol PM and other brands. Another Tylenol musty odor recall was announced last October that affected nearly 128,000 bottles.

Quality control problems at McNeil led to an FDA injunction against the company’s Fort Washington plant earlier this month. The plant will remain shut down under the decree until federal inspectors can give it a clean bill of health.

The Fort Washington plant has been closed for about a year, following the fallout from a massive recall of children’s liquid medications that affected 40 different liquid medications, including Motrin, Tylenol, Benadryl and Zyrtec. Repeated inspections at that plant and two others have consistently revealed ongoing quality control problems and have resulted in tens of millions of Johnson & Johnson products being recalled.

The ongoing problems with Johnson & Johnson have resulted in Congressional hearings and have increased the likelihood that the FDA will receive increased powers to regulate drug makers. There have also been a number of Johnson & Johnson class action and individual lawsuits filed as a result of the ongoing problems.

In addition to the recall over pesticide contamination, J&J also expanded a McNeil medications recall issued in January due to sanitary problems. The company added 717,696 bottles and packages of various Tylenol products to the recall, which was conducted at the wholesaler level. 

Consumers who purchased Tylenol affected by the latest recall are advised to stop using the product and visit the company’s website at www.tylenol.com for details on how to receive a refund or product coupon.