Extra-Strength Tylenol Recall Issued Due to Musty Odor

Johnson & Johnson continues to have problems with musty odors invading their drug products, as the company issues yet another medication recall, this time involving nearly 61,000 bottles of Extra-Strength Tylenol caplets that may be contaminated by a pesticide. 

The Extra-Strength Tylenol recall was announced on June 28 by J&J’s McNeil Consumer Healthcare division after several reports were received of uncharacteristic musty and moldy odor coming from the bottles.

The odor is believed to be caused  by a pesticide that contains the chemical 2,4,6-tribromoanisole (TBA), which has caused a number of Johnson & Johnson recalls over the last two years.

TBA is used to treat wooden pallets, and Johnson & Johnson has reported that it is fighting to eliminate any risk of contamination from its supply chain, however the bottles recalled on Tuesday were actually manufactured in February 2009, before such efforts began. No illnesses have been reported in connection with the contaminated Tylenol bottles, but TBA has been known to cause temporary gastrointestinal illness.

The recall affects one lot of Tylenol Extra Strength Caplets in 225-count bottles distributed in the U.S. The 60,912 recalled bottles have a lot number of ABA619 and UPC Code 300450444271. The lot number can be found on the side of the bottle label. Many of these bottles, given the age, have likely already been used by consumers.

The latest recall comes less than two weeks after Johnson & Johnson was also forced to recall about 16,000 bottles of Risperdal, an antidepressant, for the same problem.

Johnson & Johnson has been battling the odor problems with their drug products 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 United States, Central America and the Caribbean. The recall ultimately included Benadryl, Motrin, Tylenol PM and other brands. 

Another Tylenol musty odor recall was announced in March that affected nearly 35,000 bottles. The odor problems have also led to a Topamax recall and a Prezista recall this year as well.

Quality control problems at McNeil led to an FDA injunction against the company’s Fort Washington plant in March, following a recall of tens of millions of packages of liquid medications, which were unrelated to the TBA problems. The plant will remain shut down under the decree until federal inspectors can give it a clean bill of health.

The company recommends that consumers who have bottles affected by the recall stop using the medication and contact McNeil Consumer Healthcare at 1-888-222-6036 or www.tylenol.com for information on how to receive a full refund or product coupon.