The FDA and McNeil Consumer Healthcare today announced a recall on millions of units of various over-the-counter (OTC) medications, including certain Tylenol, Motrin, Benadryl and Rolaids products. This OTC medication recall is being conducted after an investigation into reports of an unusual moldy, mildew-like smell coming from the containers, which in some cases caused gastrointestinal problems like nausea, stomach ache, vomiting and diarrhea.
The investigation by McNeil Consumer Healthcare found that the smell was caused by the presence of small amounts of the chemical 2,4,6-tribromoanisole (TBA). The issue can result from the breakdown of a chemical that is sometimes applied to wood that is used to build wood pallets. These wooden pallets are used to transport and store product packaging materials, such as the recalled OTC medications.
The health effects TBA have not been well studied, but no serious events have been documented. In December 2009, McNeil Consumer Healthcare also recalled all lots of TYLENOL Arthritis Pain 100 count with EZ-OPEN CAP related to this issue.
Consumers should call McNeil Consumer Healthcare at 1-888-222-6036 for instructions on how to obtain a replacement. Anyone with medical concerns or questions should contact their healthcare provider and report adverse reactions to the FDA’s MedWatch website at www.fda.gov/medwatch.
The product lot numbers for the recalled products can be found on the side of the bottle label. See recalled lot numbers below.
Recalled Over-The-Counter Medications:
- Children’s Motrin
- Children’s Tylenol
- Extra Strength Tylenol
- Regular Strength Tylenol
- Tylenol 8 Hour
- Tylenol Arthritis
- Tylenol PM
- Motrin IB
- Simply Sleep
- St. Joseph Aspirin
To find out if you have a product that is affected by the OTC medication recall, locate the NDC number and the lot number of the product you have. This information can be found on the box that the product was sold in and on the actual bottle itself. If you need help with finding this information, please call 1-888-222-6036.
Click Here for all affected lot numbers.