Odor Prompts Tylenol Recall

McNeil Consumer Healthcare is recalling one product lot of Tylenol 8-Hour caplets 50 count bottles to the retail level. McNeil is taking this action following a small number of complaints of a musty or moldy odor. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
 

The odor is thought to be caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. This voluntary action is being taken as a precaution and the risk of adverse medical events is remote. To date, observed events reported to McNeil for this lot were temporary and non-serious.
 

The NDC code number of the box is 50580-297-50 and the UPC number is 3 0045-0297-51 8. The lot number is BCM155, which can be found on the side of the bottle.
 

Consumers who purchased product from the lot included in this recall should stop using the product and contact McNeil Consumer Healthcare, either at www.tylenol.com or by calling 1-888-222-6036 for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.

With the wave of recalls, McNeil Consumer Healthcare developed a Web site to provide consumers with information on the company’s product recalls. The site provides information about recalled products, a newsroom, and a Frequently Asked Questions section.
 

The company’s Consumer Care Center is available to answer questions about product recalls and provide information about receiving a refund or coupon for recalled products.

Any adverse reactions may also be reported to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.