Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Rolaids Recall
Containers' Moldy Odor to Blame for Recall of 60 Million Over-the-Counter Products
Jan. 15, 2010 -- Because of a sickening smell in some containers, 54 million
packages of 27 different over-the-counter remedies now are being recalled.
Products include various types of child and/or adult Tylenol, Motrin,
Benadryl, St. Joseph Aspirin, Rolaids, and Simply Sleep. This adds to the 6
million packages of Tylenol recalled late last year, bringing the total number
of recalled products to 60 million.
A musty, moldy odor coming from the products has sickened at least 70 people
with nausea, stomach pain, vomiting, and diarrhea. The symptoms go away by
themselves and no one has been seriously injured.
The FDA says Johnson & Johnson's McNeil Consumer Health Care knew of the
problem for more than a year. When the company did act in November and December
2008, it did too little too late, said Deborah M. Autor, director of the FDA's
Office of Compliance.
"When something smells bad, literally or figuratively, companies must
aggressively investigate and take all actions necessary to solve the problem,"
Autor said at a news conference. "McNeil should have acted faster."
The odor comes from a chemical, 2,4,6-tribromoanisole or TBA. TBA is
produced when fungi break down a commonly used fungicide called
2,4,6-tribromophenol. The full health
effects of TBA are not known.
Before being filled with product, product containers were stored on wooden
pallets apparently treated with the fungicide. TBA seems to have infiltrated
the product containers before they were filled.
The FDA inspected McNeil's main plant at Las Piedras, Puerto Rico, and was
not happy with what it found. The FDA says McNeil began receiving complaints in
May 2008, but failed to investigate fully or to warn consumers in a timely
The FDA has given McNeil 15 days to respond to its seven-point warning
letter. In addition to the contamination issue, the FDA says there are
product-quality issues with some Motrin products.
Specific products included in the recall include:
- 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
A complete list of the recalled products, including package sizes, product
types, lot numbers, and UPC codes, can be seen at www.mcneilproductrecall.com.
Consumers with question can call McNeil at 888-222-6036.
Consumers who think they may have suffered ill effects from the products
should contact the FDA at www.FDA.gov/medwatch.