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.
Dawn Casey says
My mother in law has had a stomach problem for a while now, and regularly takes rolaids. This last week her problem has grown worse, to where she has missed two days of work. In an economy like ours, nobody can afford to miss ANY work. Is the drug company going to compensate the poor people who have gotten sick because of their product?
jb emory says
Unbelievable! I have checked with McNeil and the ONLY number they have on ANY website for this recall is 888-222-6036, and yes, my Rolaids product was recalled. Can I speak with a HUMAN? NO. There is NO provision for anything but an automated informational system. I have a legitimate question about cross-contamination with storing other meds with these recalled Rolaids. I will never by another McNeil product again. And yes, I did get sick from taking the tainted Rolaids.
Jump on the bandwagon, start your stories about how bad your situation is …. Medical claims may be fruitful !!!!!!!!!!!!!
GIVE YOUR HEADs A SHAKE. The reality is there is no known serious side effect. THE CONTAMINENT IS fromTHE WOODEN PALLET. IF YOUR MEDICATION WAS SEALED, WHAT ARE THE ODDS YOU MIGHT GET A TUMMY ACHE. Was your tummy ache created by tainted food you ate or the sealed medication???
Give me a break, please. I have multiple bottles of the affected Rolaids. They are all open and I’ve taken multiple doses of them. I’m not sick, nor have I been sick. They were sealed when I bought them. Yes, plastic absorbs smells, but I am not aware of it absorbing anything else, to the point of being able to make someone sick from it. Stomach flu has been making the rounds, along with your regular run-of-the-mill food tainting. If you’ve been taking the rolaids on a regular basis, you didn’t just run into one that was bad. Yup, the lawyers will all take off running with this……… consumers beware!
I am from Montana and I had some motrin which I rarely take for an occasional back ache and when I took some on Monday morning approximately 4 hours later I got so sick, I thought I was going to die from bloating, gas, and diahrea. I thought I had ate something bad and went on with life as normal. On Tuesday evening I took some more because my back was still sore and roughly 4 hours later I was sick again and I almost went to the ER and my wife was worried because I was almost crying. Keep in mind I’m a 300 pound construction worker and the pain was almost unbearable. I still thought I might have something wrong with me like a flu or something. On Thursday I went to my shop to work to find a letter from Sam’s club letting me know that there was a recall on certain products including Motrin that I had bought. I have felt ok for over a week and tonight I looked up the reason that the recall was sent out and one of the side effects in a small number of people was exactly what I felt like with gastrointestinal problems including bloating, diahrea, vomitting, etc. So I’m not trying to get a bunch of money from the medication suppliers, but I do feel that they owe me and others at least the days of work that I missed and most of all reassurance that this is not a lasting problem that will make me sick later down the road. So to those just looking for a free ride I think like some of the others that lawyers are going to love this, but to those people I do have to say that there is some truth in the fact that we have been wronged by multi-billionare medication companies for something that most people put all their trust in to feel better. Thank You.
John Johnson says
Just so you know, my wife. who was the picture of health, had been taking the contaminated Motrin and almost died from kidney and liver failure. It started out as vomiting, diarrhea, and nausea, resulting with dialysis and a week in the hospital. Her skin peeled off, her hair fell out and her fingernails peeled off. She is still under a doctor’s care. She lost thirty pounds and has lost her taste. JUST SO YOU KNOW!
I looked at the lot numbers and one says that the medicince i have is not recalled but when i look at the ndc number and it says that its recalled. What in the world should i go by.
just so u know my 5yr old daughter has been say that her stomach has been bothering her i have been giving her benadryl bubble gum for her allergies we are going to see a doctor on fri i hope theres nothing wrong with my chid because of your benadryl and the bendryl bubble gum i have been giving her is on your recall….
I would say that if you’re taking Rolaids on a regular basis then you ALREADY have something going on with your stomach or you wouldn’t be taking them so often.
Lucy G. says
Tylenol has made me sick today felt like vomiting,deep pain in the stomach, I sweated so much it was unbearable to stand felt like I was going to die I was alone didnt know what to do called the doctor they told me to drink apple juice 5 min later I felt better MOTHER FLOWER TYLENOl
Maxine W says
I did not get sick from the rolaids, tey did have a smell, but to me anything in a plasti bottle smells, why did you take away the rolls too, they did not have a plastic bottle, DO NOT PUT THEM ON A WOODEN PALLET AND MAKE SOME MORE…….I can not live without my rolaids, please bring them back very very very soon
WHEN IS THE fda going to do somthing abut Mc neil and there products? they have had numerous problems the past year. they need to be delt with severelybefore they kill someone
i have been looking for rolaids in the little stores in my area but could not find them it wasn’t til i went to the drug store i learned they pulled rolaids i have been feeling sick to my stomach and not my self but i have problems with gerd so who knows but i can say at the same time i am feeling better was it the rolaids or just a sickness .i really do miss my rolaids they are a better antiacid then most .
Rolaids has been off the shelves for over a year and a half.
Is it really coming back?