Information about the Tylenol, Sinutab, Benadryl, Rolaids recall

The U.S. Food and Drug Administration (FDA), and McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is recalling certain lots of TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB® products distributed in the United States, the Caribbean, and Brazil.

These products were manufactured at the Fort Washington, PA plant prior to April 2010, when production at the facility was suspended. The recall is precautionary after an records found equipment cleaning procedures were insufficient or cleaning was not adequately documented. It is unlikely this impacted the quality of these products.

Certain product lots of ROLAIDS® Multi-Symptom Berry Tablets distributed in the United States, are also being recalled in order to update the labeling. The labeling does not include “Does not meet USP” as required by regulation.

No action is required by consumers and can continue to use the products. These actions are not being undertaken on the basis of adverse events.


Consumers can access full product details and other information about the recall on the http://www.mcneilproductrecall.com/ website or by calling its Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. – 8 p.m. ET and Saturday – Sunday, 9 a.m. – 5 p.m. Eastern Time).

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

•Online: www.fda.gov/MedWatch/report.htm
•Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
•Fax: 1-800-FDA-0178